Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Phase 1b Dose-Finding Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 in Patients With Advanced or Metastatic Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03307785

Enrollment

Registered

2017-10-12

Start date

2017-10-12

Completion date

2024-12-11

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Metastatic Cancer, Neoplasms, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Stage IIIB, Solid Tumor

Brief summary

Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part B: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part D: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study. Part E: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part F: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part G: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part H: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study. Part I: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.

Interventions

DRUGNiraparib

Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

DRUGTSR-042

TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).

DRUGCarboplatin-Paclitaxel

Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer \[NSCLC\], ovarian cancer, endometrial cancer, and head and neck cancer.

DRUGBevacizumab

Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.

DRUGTSR-022

TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells. TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.

DRUGCarboplatin-Pemetrexed

Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients

DRUGCarboplatin-Nab-Paclitaxel

Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient has histologically or cytologically proven advanced (unresectable) or metastatic cancer as outlined below according to study part and disease type: * Part A: Patients with previously treated advanced or metastatic cancer. Patient may have received no more than 4 lines of treatment for advanced or metastatic cancer. Hormonal treatment will not be considered a prior line of treatment. * Part B: Patients with advanced or metastatic cancer for which treatment with carboplatin-paclitaxel is considered appropriate therapy. Patient may have received no more than 1 prior line of chemotherapy in the metastatic setting. Hormonal treatment will not be considered a prior line of treatment. * Part C: Patients with previously treated advanced or metastatic cancer. Patient may have received no more than 4 lines of treatment for advanced or metastatic cancer. Hormonal treatment will not be considered a prior line of treatment. * Part D: Patients in whom carboplatin-paclitaxel and bevacizumab is considered appropriate therapy. Patient may have received no more than 1 prior line of chemotherapy in the metastatic setting. Hormonal treatment will not be considered a prior line of treatment. * Part E and F: Patients who have not received prior systemic therapy, including targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB or IV) Non-Squamous NSCLC. Patients who have received neoadjuvant or adjuvant therapy are eligible as long as development of advanced or metastatic disease occurred at least 12 months after completion of neoadjuvant or adjuvant therapy. * Part G, H, and I: Patients who have not received prior systemic therapy, including targeted therapy and biologic agents, for their advanced or metastatic (Stage ≥ IIIB or IV) NSCLC. Patients who have received neoadjuvant or adjuvant therapy are eligible as long as development of advanced or metastatic disease occurred at least 12 months after completion of neoadjuvant or adjuvant therapy. * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Patient has adequate organ function. * Female patient has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non-childbearing potential. * Male patient agrees to use an adequate method of contraception and not donate sperm starting with the first dose of study treatment through 90 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. * Patient has measurable lesions by RECIST v1.1. For Part A and C, in addition to the general inclusion criteria, patients must also meet the following additional criterion to be considered eligible to participate in this study: * Patient is able to take oral medications. * For patients to be eligible for any parts of the study using niraparib 300 mg as a starting dose, a screening actual body weight ≥ 77 kg and screening platelet count ≥ 150,000 u/L is necessary.

Exclusion criteria

(Patients will not be eligible for the study entry if any of the following criteria are met) * Patient has known active central nervous system metastases, carcinomatous meningitis, or both. * Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer. * Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection that requires systemic therapy. * Patient has a condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation * Patient is pregnant or expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment. Note: No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants from niraparib, female patients should not breastfeed during treatment with niraparib and for 1 month after receiving the final dose. * Patient has a known history of human immunodeficiency virus (type 1 or 2 antibodies). * Patient has known active hepatitis B or hepatitis C. * Patient has an active autoimmune disease that has required systemic treatment in the past 2 years. * Patient has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Patient has undergone prior treatment with a known PARP inhibitor. * Known history or current diagnosis of MDS or AML. * Patient has a known hypersensitivity to TSR-042 components or excipients. For Parts B, D, E, F, G, H, and I, patients will not be eligible for study entry if any of the following additional exclusion criterion are met: • Patient has a known hypersensitivity to any of the following relevant study treatments: carboplatin, paclitaxel, pemetrexed, nab-paclitaxel, or TSR-022 components or excipients. For Parts C and D only, patients will not be eligible for study entry if the following additional exclusion criterion is met: * Patient has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident \[CVA\]) within 6 months of enrollment. * Patient has a history of bowel obstruction, including subocclusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction. * Patient has proteinuria as demonstrated by urine protein: creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate \<2 g of protein in 24 hours to be eligible). * Patient is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months). * Patient has a known hypersensitivity to bevacizumab components or excipients. For Parts E and F only, patients will not be eligible for study entry if any of the following additional

Design outcomes

Primary

Measure	Time frame	Description
Part A: Number of Participants With Dose-limiting Toxicity (DLT)	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
Part B: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Part C: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Part D: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Part E: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Part F: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Part G: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Part H: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Part I: Number of Participants With DLT	21 days	An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	Up to 28.5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 28.5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 22.5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 9.5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 4.4 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 3.5 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 24 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 24 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Up to 24 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

Secondary

Measure	Time frame	Description
Part A: Disease Control Rate	Up to 28.5 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
Part B: Disease Control Rate	Up to 28.5 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part C: Disease Control Rate	Up to 22.5 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part D: Disease Control Rate	Up to 9.5 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part E: Disease Control Rate	Up to 4.4 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part F: Disease Control Rate	Up to 3.5 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part G: Disease Control Rate	Up to 24 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part H: Disease Control Rate	Up to 24 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part I: Disease Control Rate	Up to 24 months	Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Part A: Progression-free Survival	Up to 28.5 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part B: Progression-free Survival	Up to 28.5 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part C: Progression-free Survival	Up to 22.5 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part D: Progression-free Survival	Up to 9.5 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part E: Progression-free Survival	Up to 4.4 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part F: Progression-free Survival	Up to 3.5 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Part G: Progression-free Survival	Up to 24 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Part H: Progression-free Survival	Up to 24 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Part I: Progression-free Survival	Up to 24 months	Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 28.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 28.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 22.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 9.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 4.4 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 3.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies	Up to 3.5 months	Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part G: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 24 months	Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part H: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 24 months	Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part H: Number of Participants With Positive Anti-TSR-022 Antibodies	Up to 24 months	Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part I: Number of Participants With Positive Anti-TSR-042 Antibodies	Up to 24 months	Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part I: Number of Participants With Positive Anti-TSR-022 Antibodies	Up to 24 months	Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
Part A: AUC(0-t) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: AUC0-t of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: AUC0-t of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: AUC0-t of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: AUC0-t of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: AUC0-t of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUC0-t of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUC0-t of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: AUC0-t of TSR-042	Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUC0-t of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUC0-t of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUC0-t of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUC0-t of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: AUC(0-infinity) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: AUC(0-infinity) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: AUC(0-infinity) of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: AUC(0-infinity) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: AUC(0-infinity) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Ctau of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part E: AUC(0-infinity) of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUC(0-infinity) of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUC(0-infinity) of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: AUC(0-infinity) of TSR-042	Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUC(0-infinity) of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUC(0-infinity) of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUC(0-infinity) of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUC(0-infinity) of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Ctau of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Ctau of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Ctau of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Ctau of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Maximum Observed Plasma (Cmax) of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Cmax of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Cmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Cmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Cmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Cmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Clearance After Oral Administration (CL/F) of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: CL of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: CL/F of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: CL of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: CL of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: CL of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: CL of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: CL of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: CL of TSR-042	Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: CL of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: CL of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: CL of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: CL of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Vz of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Vz/F of Niraparib	Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Vz of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Vz of TSR-042	Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Vz of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Vz of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Vz of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Vz of TSR-042	Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Vz of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Vz of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Vz of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Vz of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: AUC at Steady State (AUCss) of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: AUCss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: AUCss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: AUCss of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: AUCss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: AUCss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: AUCss of TSR-042	Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUCss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: AUCss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: AUCss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUCss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: AUCss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUCss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: AUCss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Ctau at Steady State (Ctau,ss) of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Ctau,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Ctau,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Ctau,ss of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Ctau,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Ctau,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Ctau,ss of TSR-042	Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Ctau,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Ctau,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Ctau,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Ctau,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Ctau,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Ctau,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Ctau,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Cmax at Steady State (Cmax,ss) of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Cmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Cmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Cmax,ss of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Cmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Cmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Cmax,ss of TSR-042	Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Cmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Cmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Cmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Cmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Cmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Cmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Cmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Tmax of Niraparib	Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Tmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Tmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Tmax of TSR-042	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Tmax of TSR-022	Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Tmax at Steady State (Tmax,ss) of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part A: Tmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Tmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Tmax,ss of Niraparib	Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Part C: Tmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Tmax,ss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Tmax,ss of TSR-042	Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Tmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Tmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Tmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Tmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Tmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Tmax,ss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Tmax,ss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Objective Response Rate	Up to 28.5 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part B: Vss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part C: Vss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part D: Vss of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part E: Vss of TSR-042	Cycle 2: Pre-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Vss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part F: Vss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Part G: Vss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Vss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part H: Vss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Vss of TSR-042	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part I: Vss of TSR-022	Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)	Blood samples were planned to be collected at indicated time points.
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)	Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Part B: Objective Response Rate	Up to 28.5 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part C: Objective Response Rate	Up to 22.5 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part D: Objective Response Rate	Up to 9.5 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part E: Objective Response Rate	Up to 4.4 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part F: Objective Response Rate	Up to 3.5 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part G: Objective Response Rate	Up to 24 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part H: Objective Response Rate	Up to 24 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part I: Objective Response Rate	Up to 24 months	Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Part A: Duration of Response	Up to 28.5 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part B: Duration of Response	Up to approximately 66 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part C: Duration of Response	Up to approximately 60 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part D: Duration of Response	Up to approximately 62.5 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part E: Duration of Response	Up to 4.4 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part F: Duration of Response	Up to 3.5 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part G: Duration of Response	Up to 24 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part H: Duration of Response	Up to 24 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Part I: Duration of Response	Up to 24 months	Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Countries

United States

Participant flow

Recruitment details

A total of 60 participants were enrolled in the study and 2 participants who originally signed inform consent form (ICF) withdrew their consent shortly from study before treatment assignment and a total of 58 participants were part of the study.

Pre-assignment details

The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. Main Study Phase was planned to be a nine-part study with Parts A to I. However, Parts G, H and I were not initiated due to business strategic reason. In PACT phase those participants benefiting from treatment continued to receive study drug until discontinuation or withdrawal from study.

Participants by arm

Arm	Count
Main Study: Part A: TSR-042 and Niraparib 200 mg QD Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.	16
Main Study: Part A: TSR-042 and Niraparib 300 mg QD Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.	6
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.	14
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	6
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	7
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.	6
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).	2
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).	1
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.	0
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.	0
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).	0
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG012
Main Study: Part A: Up to 28.5 Months	Death	4	4	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months	Disease progression	2	0	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months	Physician Decision	3	1	0	0	0	0	0	0	0
Main Study: Part A: Up to 28.5 Months	Withdrawal by Subject	7	1	0	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months	Death	0	0	7	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months	Disease progression	0	0	2	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months	Physician Decision	0	0	1	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months	Transitioned to PACT phase	0	0	2	0	0	0	0	0	0
MainStudy: PartB: Up to Approx.66months	Withdrawal by Subject	0	0	2	0	0	0	0	0	0
MainStudy: PartC:Up to Approx.60months	Death	0	0	0	2	5	0	0	0	0
MainStudy: PartC:Up to Approx.60months	Physician Decision	0	0	0	3	1	0	0	0	0
MainStudy: PartC:Up to Approx.60months	Went on Another Clinical Trial	0	0	0	0	1	0	0	0	0
MainStudy: PartC:Up to Approx.60months	Withdrawal by Subject	0	0	0	1	0	0	0	0	0
MainStudy:PartD:Up to Approx. 62.5months	Completed EOT and Began New Study	0	0	0	0	0	1	0	0	0
MainStudy:PartD:Up to Approx. 62.5months	Death	0	0	0	0	0	1	0	0	0
MainStudy:PartD:Up to Approx. 62.5months	Physician Decision	0	0	0	0	0	2	0	0	0
MainStudy:PartD:Up to Approx. 62.5months	Transitioned to PACT phase	0	0	0	0	0	1	0	0	0
MainStudy:PartD:Up to Approx. 62.5months	Withdrawal by Subject	0	0	0	0	0	1	0	0	0
Main Study: Part E: Up to 4.4 Months	Death	0	0	0	0	0	0	1	0	0
Main Study: Part E: Up to 4.4 Months	Physician Decision	0	0	0	0	0	0	1	0	0
Main Study: Part F: Up to 3.5 Months	Physician Decision	0	0	0	0	0	0	0	1	0
PACT Phase: Up to 19 Months	Death	0	0	0	0	0	0	0	0	1

Baseline characteristics

Characteristic	Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Main Study: Part B: TSR-042 and Carboplatin-paclitaxel	Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab	Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab	Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab	Main Study: Part E: TSR-042 and Carboplatin-pemetrexed	Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed	Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel	Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel	Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel	Total
Age, Customized 18-64 years	3 Participants	5 Participants	4 Participants	6 Participants	2 Participants	1 Participants	8 Participants	1 Participants	0 Participants	0 Participants	0 Participants	30 Participants
Age, Customized 65-74 years	1 Participants	4 Participants	2 Participants	1 Participants	3 Participants	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants	17 Participants
Age, Customized >=75 years	2 Participants	5 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	11 Participants
Race/Ethnicity, Customized Black or African American	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	NA Participants	0 Participants	0 Participants	0 Participants	NA Participants
Race/Ethnicity, Customized White	5 Participants	13 Participants	6 Participants	5 Participants	6 Participants	1 Participants	16 Participants	NA Participants	0 Participants	0 Participants	0 Participants	NA Participants
Sex: Female, Male Female	2 Participants	8 Participants	4 Participants	7 Participants	5 Participants	0 Participants	9 Participants	NA Participants	0 Participants	0 Participants	0 Participants	NA Participants
Sex: Female, Male Male	4 Participants	6 Participants	2 Participants	0 Participants	1 Participants	2 Participants	7 Participants	NA Participants	0 Participants	0 Participants	0 Participants	NA Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	4 / 16	4 / 6	7 / 14	2 / 6	5 / 7	1 / 6	1 / 2	0 / 1	0 / 2	1 / 1
other Total, other adverse events	16 / 16	6 / 6	14 / 14	5 / 6	7 / 7	6 / 6	2 / 2	1 / 1	0 / 2	0 / 1
serious Total, serious adverse events	11 / 16	4 / 6	9 / 14	3 / 6	3 / 7	3 / 6	2 / 2	0 / 1	0 / 2	1 / 1

Outcome results

Primary

Part A: Number of Participants With Dose-limiting Toxicity (DLT)

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).

Time frame: 21 days

Population: Safety Population consisted of all participants who received any amount of study treatment.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Number of Participants With Dose-limiting Toxicity (DLT)	2 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Number of Participants With Dose-limiting Toxicity (DLT)	0 Participants

Primary

Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	Non-serious TEAEs	16 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	STEAEs	11 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	AESIs	1 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	Non-serious TEAEs	6 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	STEAEs	4 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)	AESIs	1 Participants

Primary

Part B: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Number of Participants With DLT	1 Participants

Primary

Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-Serious TEAEs	14 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	9 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants

Primary

Part C: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Number of Participants With DLT	1 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Number of Participants With DLT	1 Participants

Primary

Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 22.5 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-serious TEAEs	5 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	3 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-serious TEAEs	7 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	3 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants

Primary

Part D: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Number of Participants With DLT	0 Participants

Primary

Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 9.5 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-serious TEAEs	6 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	3 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants

Primary

Part E: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Number of Participants With DLT	0 Participants

Primary

Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 4.4 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-serious TEAEs	2 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	2 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants

Primary

Part F: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With DLT	0 Participants

Primary

Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 3.5 months

Population: Safety Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	Non-serious TEAEs	1 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	STEAEs	0 Participants
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs	AESIs	0 Participants

Primary

Part G: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Primary

Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Primary

Part H: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Primary

Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Primary

Part I: Number of Participants With DLT

An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.

Time frame: 21 days

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Primary

Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib	NA Hours*microgram per milliliter
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib	NA Hours*microgram per milliliter

Secondary

Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib

Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib	Cycle 1, n=15,6	6.0430 Hours*microgram per milliliter	Standard Deviation 3.43261
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib	Cycle 2, n=10,3	14.9172 Hours*microgram per milliliter	Standard Deviation 9.82689
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib	Cycle 1, n=15,6	7.8341 Hours*microgram per milliliter	Standard Deviation 4.7638
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib	Cycle 2, n=10,3	29.3024 Hours*microgram per milliliter	Standard Deviation 2.15129

Secondary

Part A: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part A: AUC(0-t) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 5, n=8,1	137108.2574 Hours*microgram per milliliter	Standard Deviation 41494.15474
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 4, n=9,4	55408.3992 Hours*microgram per milliliter	Standard Deviation 21631.17124
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 11, n=5,0	139591.8834 Hours*microgram per milliliter	Standard Deviation 53844.1265
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 1, n=16,6	26827.7703 Hours*microgram per milliliter	Standard Deviation 9811.74994
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 4, n=9,4	29311.8182 Hours*microgram per milliliter	Standard Deviation 16546.73177
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 1, n=16,6	29420.8347 Hours*microgram per milliliter	Standard Deviation 9262.18751
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUC(0-t) of TSR-042	Cycle 5, n=8,1	141328.9288 Hours*microgram per milliliter	—

Secondary

Part A: AUC at Steady State (AUCss) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUC at Steady State (AUCss) of Niraparib	16.3481 Hours*microgram per milliliter	Standard Deviation 10.63803
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUC at Steady State (AUCss) of Niraparib	29.4312 Hours*microgram per milliliter	—

Secondary

Part A: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUCss of TSR-042	Cycle 11, n=4,0	151575.3645 Hours*microgram per milliliter	Standard Deviation 55194.65972
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUCss of TSR-042	Cycle 4, n=7,2	58598.5076 Hours*microgram per milliliter	Standard Deviation 15328.61731
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: AUCss of TSR-042	Cycle 5, n=8,1	135171.2753 Hours*microgram per milliliter	Standard Deviation 43806.32512
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUCss of TSR-042	Cycle 4, n=7,2	46122.3924 Hours*microgram per milliliter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: AUCss of TSR-042	Cycle 5, n=8,1	141306.3782 Hours*microgram per milliliter	—

Secondary

Part A: Clearance After Intravenous Administration (CL) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 4, n=7,2	0.0090 Liter per hour	Standard Deviation 0.0022
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 5, n=8,1	0.0081 Liter per hour	Standard Deviation 0.00238
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 11, n=4,0	0.0072 Liter per hour	Standard Deviation 0.00217
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 4, n=7,2	0.0110 Liter per hour	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 5, n=8,1	0.0071 Liter per hour	—
Unknown	Part A: Clearance After Intravenous Administration (CL) of TSR-042	Cycle 1, n=0,0	— Liter per hour	—

Secondary

Part A: Clearance After Oral Administration (CL/F) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Clearance After Oral Administration (CL/F) of Niraparib	Cycle 1, n=1,0	28.5638 Liter per hour	—
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Clearance After Oral Administration (CL/F) of Niraparib	Cycle 2, n=8,2	16.6295 Liter per hour	Standard Deviation 8.70836
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Clearance After Oral Administration (CL/F) of Niraparib	Cycle 2, n=8,2	10.2833 Liter per hour	—

Secondary

Part A: Cmax at Steady State (Cmax,ss) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax at Steady State (Cmax,ss) of Niraparib	Cycle 2, n=10,3	0.925900 Microgram per milliliter	Standard Deviation 0.6661597
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax at Steady State (Cmax,ss) of Niraparib	Cycle 5, n=7,0	0.839071 Microgram per milliliter	Standard Deviation 0.6183628
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax at Steady State (Cmax,ss) of Niraparib	Cycle 11, n=2,0	0.768000 Microgram per milliliter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Cmax at Steady State (Cmax,ss) of Niraparib	Cycle 2, n=10,3	1.706667 Microgram per milliliter	Standard Deviation 0.083865

Secondary

Part A: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax of TSR-042	158.6875 Microgram per milliliter	Standard Deviation 27.70251
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Cmax of TSR-042	138.9167 Microgram per milliliter	Standard Deviation 37.8793

Secondary

Part A: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax,ss of TSR-042	Cycle 4, n=9,4	222.5556 Microgram per milliliter	Standard Deviation 51.37633
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax,ss of TSR-042	Cycle 5, n=8,1	393.8750 Microgram per milliliter	Standard Deviation 100.81729
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Cmax,ss of TSR-042	Cycle 11, n=5,0	405.4000 Microgram per milliliter	Standard Deviation 103.69812
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Cmax,ss of TSR-042	Cycle 4, n=9,4	178.5000 Microgram per milliliter	Standard Deviation 26.18524
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Cmax,ss of TSR-042	Cycle 5, n=8,1	319.0000 Microgram per milliliter	—

Secondary

Part A: Ctau at Steady State (Ctau,ss) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Ctau at Steady State (Ctau,ss) of Niraparib	Cycle 2, n=11,6	0.507900 Microgram per milliliter	Standard Deviation 0.3937657
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Ctau at Steady State (Ctau,ss) of Niraparib	Cycle 2, n=11,6	0.622000 Microgram per milliliter	Standard Deviation 0.4523848

Secondary

Part A: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Ctau of TSR-042	33.6000 Microgram per milliliter	Standard Deviation 12.25194
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Ctau of TSR-042	29.8000 Microgram per milliliter	Standard Deviation 10.3257

Secondary

Part A: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Ctau,ss of TSR-042	Cycle 4, n=8,1	77.3625 Microgram per milliliter	Standard Deviation 28.55145
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Ctau,ss of TSR-042	Cycle 5, n=8,1	68.5500 Microgram per milliliter	Standard Deviation 34.63879
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Ctau,ss of TSR-042	Cycle 11, n=4,0	93.8000 Microgram per milliliter	Standard Deviation 47.28939
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Ctau,ss of TSR-042	Cycle 4, n=8,1	63.3000 Microgram per milliliter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Ctau,ss of TSR-042	Cycle 5, n=8,1	71.2000 Microgram per milliliter	—

Secondary

Part A: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Disease Control Rate	43.8 Percentage of participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Disease Control Rate	33.3 Percentage of participants

Secondary

Part A: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Duration of Response	7.59 Months
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Duration of Response	NA Months

Secondary

Part A: Maximum Observed Plasma (Cmax) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Maximum Observed Plasma (Cmax) of Niraparib	0.460600 Microgram per milliliter	Standard Deviation 0.24011
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Maximum Observed Plasma (Cmax) of Niraparib	0.625667 Microgram per milliliter	Standard Deviation 0.4547692

Secondary

Part A: Number of Participants With Positive Anti-TSR-042 Antibodies

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.

Time frame: Up to 28.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants

Secondary

Part A: Objective Response Rate

Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Objective Response Rate	25.0 Percentage of participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Objective Response Rate	0 Percentage of participants

Secondary

Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib	0.191953 Microgram per milliliter	Standard Deviation 0.1309536
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib	0.342333 Microgram per milliliter	Standard Deviation 0.3301392

Secondary

Part A: Progression-free Survival

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Progression-free Survival	6.2 Months
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Progression-free Survival	2.8 Months

Secondary

Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib	2.250 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib	4.083 Hours

Secondary

Part A: Tmax at Steady State (Tmax,ss) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax at Steady State (Tmax,ss) of Niraparib	Cycle 2, n=10,3	4.008 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax at Steady State (Tmax,ss) of Niraparib	Cycle 5, n=7,0	2.000 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax at Steady State (Tmax,ss) of Niraparib	Cycle 11, n=2,0	1.817 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Tmax at Steady State (Tmax,ss) of Niraparib	Cycle 2, n=10,3	2.250 Hours

Secondary

Part A: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax of TSR-042	0.817 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Tmax of TSR-042	1.750 Hours

Secondary

Part A: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax,ss of TSR-042	Cycle 4, n=9,4	1.500 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax,ss of TSR-042	Cycle 5, n=8,1	0.625 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Tmax,ss of TSR-042	Cycle 11, n=5,0	0.567 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Tmax,ss of TSR-042	Cycle 4, n=9,4	1.300 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Tmax,ss of TSR-042	Cycle 5, n=8,1	2.783 Hours

Secondary

Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 4, n=5,2	5.5647 Liter	Standard Deviation 1.36694
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 5, n=8,1	6.6580 Liter	Standard Deviation 1.53521
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 11, n=4,0	7.3107 Liter	Standard Deviation 0.96007
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 4, n=5,2	9.8680 Liter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042	Cycle 5, n=8,1	5.9659 Liter	—

Secondary

Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 4, n=5,2	5.6925 Liter	Standard Deviation 1.46062
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 5, n=8,1	6.8811 Liter	Standard Deviation 1.70545
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 11, n=4,0	7.4795 Liter	Standard Deviation 0.90952
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 4, n=5,2	10.3984 Liter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 5, n=8,1	6.3070 Liter	—
Unknown	Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042	Cycle 1, n=0,0	— Liter	—

Secondary

Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib	Cycle 1, n=1,0	380.1478 Liter	—
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib	Cycle 2, n=8,2	716.1418 Liter	Standard Deviation 554.80278
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib	Cycle 2, n=8,2	487.8826 Liter	—

Secondary

Part B: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part B: AUC0-t of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUC0-t of TSR-042	Cycle 1, n=14	28097.9846 Hours*microgram per milliliter	Standard Deviation 8440.50578
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUC0-t of TSR-042	Cycle 4, n=10	54730.0053 Hours*microgram per milliliter	Standard Deviation 15857.69305
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUC0-t of TSR-042	Cycle 5, n=9	124309.5455 Hours*microgram per milliliter	Standard Deviation 56505.10671
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUC0-t of TSR-042	Cycle 11, n=6	117030.4081 Hours*microgram per milliliter	Standard Deviation 33852.45635

Secondary

Part B: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUCss of TSR-042	Cycle 4, n=10	55073.0926 Hours*microgram per milliliter	Standard Deviation 15304.21896
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUCss of TSR-042	Cycle 5, n=8	130694.9752 Hours*microgram per milliliter	Standard Deviation 33923.75772
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: AUCss of TSR-042	Cycle 11, n=6	117033.3612 Hours*microgram per milliliter	Standard Deviation 33727.51653

Secondary

Part B: CL of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: CL of TSR-042	Cycle 4, n=10	0.0098 Liter per hour	Standard Deviation 0.00292
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: CL of TSR-042	Cycle 5, n=8	0.0082 Liter per hour	Standard Deviation 0.00242
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: CL of TSR-042	Cycle 11, n=6	0.0092 Liter per hour	Standard Deviation 0.00296
Unknown	Part B: CL of TSR-042	Cycle 1, n=0	— Liter per hour	—

Secondary

Part B: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Cmax of TSR-042	148.2000 Microgram per milliliter	Standard Deviation 31.27948

Secondary

Part B: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Cmax,ss of TSR-042	Cycle 4, n=10	225.8000 Microgram per milliliter	Standard Deviation 51.7146
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Cmax,ss of TSR-042	Cycle 5, n=9	421.1111 Microgram per milliliter	Standard Deviation 114.84603
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Cmax,ss of TSR-042	Cycle 11, n=6	446.6667 Microgram per milliliter	Standard Deviation 160.53868

Secondary

Part B: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Ctau of TSR-042	33.9778 Microgram per milliliter	Standard Deviation 9.89846

Secondary

Part B: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Ctau,ss of TSR-042	Cycle 4, n=9	67.2444 Microgram per milliliter	Standard Deviation 24.1513
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Ctau,ss of TSR-042	Cycle 5, n=8	59.3000 Microgram per milliliter	Standard Deviation 16.75913
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Ctau,ss of TSR-042	Cycle 11, n=6	57.4833 Microgram per milliliter	Standard Deviation 20.98136

Secondary

Part B: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Disease Control Rate	57.1 Percentage of participants

Secondary

Part B: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to approximately 66 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Duration of Response	NA Months

Secondary

Part B: Number of Participants With Positive Anti-TSR-042 Antibodies

Time frame: Up to 28.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Number of Participants With Positive Anti-TSR-042 Antibodies	4 Participants

Secondary

Part B: Objective Response Rate

Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Objective Response Rate	42.9 Percentage of participants

Secondary

Part B: Progression-free Survival

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.

Time frame: Up to 28.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Progression-free Survival	17.6 Months

Secondary

Part B: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Tmax of TSR-042	1.000 Hours

Secondary

Part B: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Tmax,ss of TSR-042	Cycle 4, n=10	0.575 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Tmax,ss of TSR-042	Cycle 5, n=9	1.500 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Tmax,ss of TSR-042	Cycle 11, n=6	0.542 Hours

Secondary

Part B: Vss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vss of TSR-042	Cycle 4, n=10	5.1893 Liter	Standard Deviation 1.80311
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vss of TSR-042	Cycle 5, n=8	6.7701 Liter	Standard Deviation 2.31992
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vss of TSR-042	Cycle 11, n=6	7.4351 Liter	Standard Deviation 2.78481

Secondary

Part B: Vz of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vz of TSR-042	Cycle 4, n=10	5.3661 Liter	Standard Deviation 2.01321
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vz of TSR-042	Cycle 5, n=8	7.2627 Liter	Standard Deviation 2.43311
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part B: Vz of TSR-042	Cycle 11, n=6	8.0529 Liter	Standard Deviation 3.64454
Unknown	Part B: Vz of TSR-042	Cycle 1, n=0	— Liter	—

Secondary

Part C: AUC(0-infinity) of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC(0-infinity) of Niraparib	NA Hours*microgram per milliliter
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC(0-infinity) of Niraparib	NA Hours*microgram per milliliter

Secondary

Part C: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part C: AUC0-t of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of Niraparib	Cycle 1, n=6,7	3.4513 Hours*microgram per milliliter	Standard Deviation 1.23048
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of Niraparib	Cycle 2, n=4,4	14.7473 Hours*microgram per milliliter	Standard Deviation 8.11715
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of Niraparib	Cycle 1, n=6,7	11.3601 Hours*microgram per milliliter	Standard Deviation 5.53524
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of Niraparib	Cycle 2, n=4,4	24.9691 Hours*microgram per milliliter	Standard Deviation 17.50367

Secondary

Part C: AUC0-t of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of TSR-042	Cycle 1, n=6,7	29830.6542 Hours*microgram per milliliter	Standard Deviation 8143.36941
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of TSR-042	Cycle 4, n=5,7	54268.1379 Hours*microgram per milliliter	Standard Deviation 14777.09545
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of TSR-042	Cycle 5, n=5,6	137777.3188 Hours*microgram per milliliter	Standard Deviation 45794.21973
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUC0-t of TSR-042	Cycle 11, n=4,2	143070.3093 Hours*microgram per milliliter	Standard Deviation 74219.00272
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of TSR-042	Cycle 11, n=4,2	119161.8795 Hours*microgram per milliliter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of TSR-042	Cycle 1, n=6,7	26311.1789 Hours*microgram per milliliter	Standard Deviation 4416.61957
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of TSR-042	Cycle 5, n=5,6	131281.9046 Hours*microgram per milliliter	Standard Deviation 36835.3973
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUC0-t of TSR-042	Cycle 4, n=5,7	49198.8237 Hours*microgram per milliliter	Standard Deviation 12507.66126

Secondary

Part C: AUCss of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUCss of Niraparib	21.4926 Hours*microgram per milliliter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUCss of Niraparib	26.5006 Hours*microgram per milliliter	Standard Deviation 14.61077

Secondary

Part C: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUCss of TSR-042	Cycle 4, n=5,5	55974.4268 Hours*microgram per milliliter	Standard Deviation 16738.05254
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUCss of TSR-042	Cycle 5, n=5,6	137399.5881 Hours*microgram per milliliter	Standard Deviation 45511.62023
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: AUCss of TSR-042	Cycle 11, n=4,2	147907.5379 Hours*microgram per milliliter	Standard Deviation 60795.87607
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUCss of TSR-042	Cycle 4, n=5,5	50924.1510 Hours*microgram per milliliter	Standard Deviation 13339.28085
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUCss of TSR-042	Cycle 5, n=5,6	131288.0291 Hours*microgram per milliliter	Standard Deviation 36816.18787
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: AUCss of TSR-042	Cycle 11, n=4,2	119189.5905 Hours*microgram per milliliter	—

Secondary

Part C: CL/F of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: CL/F of Niraparib	Cycle 2, n=2,4	10.3777 Liter per hour	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: CL/F of Niraparib	Cycle 2, n=2,4	14.4947 Liter per hour	Standard Deviation 8.40967
Unknown	Part C: CL/F of Niraparib	Cycle 1, n=0,0	— Liter per hour	—

Secondary

Part C: CL of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: CL of TSR-042	Cycle 5, n=5,6	0.0082 Liter per hour	Standard Deviation 0.0037
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: CL of TSR-042	Cycle 4, n=5,5	0.0100 Liter per hour	Standard Deviation 0.00441
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: CL of TSR-042	Cycle 11, n=4,2	0.0079 Liter per hour	Standard Deviation 0.00391
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: CL of TSR-042	Cycle 5, n=5,6	0.0082 Liter per hour	Standard Deviation 0.00273
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: CL of TSR-042	Cycle 11, n=4,2	0.0086 Liter per hour	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: CL of TSR-042	Cycle 4, n=5,5	0.0104 Liter per hour	Standard Deviation 0.00268
Unknown	Part C: CL of TSR-042	Cycle 1, n=0,0	— Liter per hour	—

Secondary

Part C: Cmax of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax of Niraparib	0.243667 Microgram per milliliter	Standard Deviation 0.0889936
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax of Niraparib	0.891571 Microgram per milliliter	Standard Deviation 0.4638897

Secondary

Part C: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax of TSR-042	138.6667 Microgram per milliliter	Standard Deviation 24.14677
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax of TSR-042	158.4857 Microgram per milliliter	Standard Deviation 48.36788

Secondary

Part C: Cmax,ss of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of Niraparib	Cycle 2, n=4,4	0.854500 Microgram per milliliter	Standard Deviation 0.3934637
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of Niraparib	Cycle 5, n=4,3	0.709750 Microgram per milliliter	Standard Deviation 0.2693788
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of Niraparib	Cycle 11, n=3,1	0.468333 Microgram per milliliter	Standard Deviation 0.1418955
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of Niraparib	Cycle 2, n=4,4	1.404750 Microgram per milliliter	Standard Deviation 0.6642366
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of Niraparib	Cycle 5, n=4,3	1.073667 Microgram per milliliter	Standard Deviation 0.5474124
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of Niraparib	Cycle 11, n=3,1	0.638000 Microgram per milliliter	—

Secondary

Part C: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of TSR-042	Cycle 4, n=5,7	234.4000 Microgram per milliliter	Standard Deviation 31.76948
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of TSR-042	Cycle 5, n=5,6	325.2000 Microgram per milliliter	Standard Deviation 73.90332
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Cmax,ss of TSR-042	Cycle 11, n=4,2	349.7500 Microgram per milliliter	Standard Deviation 111.53886
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of TSR-042	Cycle 4, n=5,7	227.1429 Microgram per milliliter	Standard Deviation 42.65923
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of TSR-042	Cycle 5, n=5,6	417.3333 Microgram per milliliter	Standard Deviation 139.40397
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Cmax,ss of TSR-042	Cycle 11, n=4,2	321.0000 Microgram per milliliter	—

Secondary

Part C: Ctau of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau of Niraparib	0.161233 Microgram per milliliter	Standard Deviation 0.1072328
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau of Niraparib	0.478714 Microgram per milliliter	Standard Deviation 0.4197538

Secondary

Part C: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau of TSR-042	37.2750 Microgram per milliliter	Standard Deviation 16.78102
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau of TSR-042	28.7500 Microgram per milliliter	Standard Deviation 9.47505

Secondary

Part C: Ctau,ss of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau,ss of Niraparib	Cycle 2, n=5,4	0.484000 Microgram per milliliter	Standard Deviation 0.3511339
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau,ss of Niraparib	Cycle 2, n=5,4	1.094250 Microgram per milliliter	Standard Deviation 0.7660576

Secondary

Part C: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau,ss of TSR-042	Cycle 4, n=4,6	70.4250 Microgram per milliliter	Standard Deviation 34.00896
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau,ss of TSR-042	Cycle 5, n=5,6	82.9800 Microgram per milliliter	Standard Deviation 43.98252
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Ctau,ss of TSR-042	Cycle 11, n=3,2	105.4667 Microgram per milliliter	Standard Deviation 22.28909
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau,ss of TSR-042	Cycle 4, n=4,6	64.2667 Microgram per milliliter	Standard Deviation 23.55315
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau,ss of TSR-042	Cycle 5, n=5,6	53.1500 Microgram per milliliter	Standard Deviation 24.80538
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Ctau,ss of TSR-042	Cycle 11, n=3,2	60.9500 Microgram per milliliter	—

Secondary

Part C: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 22.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Disease Control Rate	83.3 Percentage of participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Disease Control Rate	85.7 Percentage of participants

Secondary

Part C: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to approximately 60 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Duration of Response	NA Months
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Duration of Response	NA Months

Secondary

Part C: Number of Participants With Positive Anti-TSR-042 Antibodies

Time frame: Up to 22.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants

Secondary

Part C: Objective Response Rate

Time frame: Up to 22.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Objective Response Rate	50.0 Percentage of participants
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Objective Response Rate	14.3 Percentage of participants

Secondary

Part C: Progression-free Survival

Time frame: Up to 22.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Progression-free Survival	NA Months
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Progression-free Survival	9.1 Months

Secondary

Part C: Tmax of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax of Niraparib	3.975 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax of Niraparib	4.050 Hours

Secondary

Part C: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax of TSR-042	1.200 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax of TSR-042	0.583 Hours

Secondary

Part C: Tmax,ss of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of Niraparib	Cycle 2, n=4,4	4.950 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of Niraparib	Cycle 5, n=4,3	2.158 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of Niraparib	Cycle 11, n=3,1	2.000 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of Niraparib	Cycle 2, n=4,4	3.958 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of Niraparib	Cycle 5, n=4,3	1.967 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of Niraparib	Cycle 11, n=3,1	2.083 Hours

Secondary

Part C: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of TSR-042	Cycle 4, n=5,7	1.517 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of TSR-042	Cycle 5, n=5,6	2.083 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Tmax,ss of TSR-042	Cycle 11, n=4,2	2.000 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of TSR-042	Cycle 11, n=4,2	2.417 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of TSR-042	Cycle 4, n=5,7	0.617 Hours
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Tmax,ss of TSR-042	Cycle 5, n=5,6	0.825 Hours

Secondary

Part C: Vss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vss of TSR-042	Cycle 4, n=5,5	6.4567 Liter	Standard Deviation 2.68944
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vss of TSR-042	Cycle 5, n=4,6	6.2405 Liter	Standard Deviation 1.79539
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vss of TSR-042	Cycle 11, n=4,2	8.9478 Liter	Standard Deviation 3.05769
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vss of TSR-042	Cycle 4, n=5,5	5.5177 Liter	Standard Deviation 2.39652
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vss of TSR-042	Cycle 5, n=4,6	4.8035 Liter	Standard Deviation 0.72905
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vss of TSR-042	Cycle 11, n=4,2	7.7750 Liter	—

Secondary

Part C: Vz/F of Niraparib

Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.

Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vz/F of Niraparib	Cycle 2, n=2,2	551.4003 Liter
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vz/F of Niraparib	Cycle 2, n=2,2	559.3634 Liter
Unknown	Part C: Vz/F of Niraparib	Cycle 1, n=0,0	— Liter

Secondary

Part C: Vz of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vz of TSR-042	Cycle 5, n=4,6	6.1698 Liter	Standard Deviation 1.73272
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vz of TSR-042	Cycle 4, n=5,5	6.6462 Liter	Standard Deviation 2.66825
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part C: Vz of TSR-042	Cycle 11, n=4,2	9.6347 Liter	Standard Deviation 4.05466
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vz of TSR-042	Cycle 5, n=4,6	5.2066 Liter	Standard Deviation 1.07206
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vz of TSR-042	Cycle 11, n=4,2	8.5098 Liter	—
Main Study: Part A: TSR-042 and Niraparib 300 mg QD	Part C: Vz of TSR-042	Cycle 4, n=5,5	5.8922 Liter	Standard Deviation 2.93257
Unknown	Part C: Vz of TSR-042	Cycle 1, n=0,0	— Liter	—

Secondary

Part D: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part D: AUC0-t of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUC0-t of TSR-042	Cycle 1, n=6	32819.5401 Hours*microgram per milliliter	Standard Deviation 9182.44511
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUC0-t of TSR-042	Cycle 4, n=5	52409.0255 Hours*microgram per milliliter	Standard Deviation 11814.13244
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUC0-t of TSR-042	Cycle 5, n=5	119847.0999 Hours*microgram per milliliter	Standard Deviation 27279.85524
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUC0-t of TSR-042	Cycle 11, n=4	77794.6422 Hours*microgram per milliliter	Standard Deviation 38680.64753

Secondary

Part D: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUCss of TSR-042	Cycle 4, n=5	51140.4410 Hours*microgram per milliliter	Standard Deviation 12597.0738
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUCss of TSR-042	Cycle 5, n=5	118845.3928 Hours*microgram per milliliter	Standard Deviation 27874.98871
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: AUCss of TSR-042	Cycle 11, n=3	96800.1534 Hours*microgram per milliliter	Standard Deviation 8871.32089

Secondary

Part D: CL of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: CL of TSR-042	Cycle 4, n=5	0.0102 Liter per hour	Standard Deviation 0.0021
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: CL of TSR-042	Cycle 5, n=5	0.0087 Liter per hour	Standard Deviation 0.00169
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: CL of TSR-042	Cycle 11, n=3	0.0104 Liter per hour	Standard Deviation 0.001
Unknown	Part D: CL of TSR-042	Cycle 1, n=0	— Liter per hour	—

Secondary

Part D: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Cmax of TSR-042	188.5000 Microgram per milliliter	Standard Deviation 36.04858

Secondary

Part D: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Cmax,ss of TSR-042	Cycle 4, n=5	256.8000 Microgram per milliliter	Standard Deviation 76.90709
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Cmax,ss of TSR-042	Cycle 5, n=5	416.0000 Microgram per milliliter	Standard Deviation 89.43433
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Cmax,ss of TSR-042	Cycle 11, n=4	429.7500 Microgram per milliliter	Standard Deviation 72.86231

Secondary

Part D: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Ctau of TSR-042	36.5250 Microgram per milliliter	Standard Deviation 12.29834

Secondary

Part D: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Ctau,ss of TSR-042	Cycle 4, n=5	53.5200 Microgram per milliliter	Standard Deviation 13.87271
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Ctau,ss of TSR-042	Cycle 5, n=5	48.0800 Microgram per milliliter	Standard Deviation 23.95343
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Ctau,ss of TSR-042	Cycle 11, n=3	43.3000 Microgram per milliliter	Standard Deviation 4.80729

Secondary

Part D: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 9.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Disease Control Rate	83.3 Percentage of participants

Secondary

Part D: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to approximately 62.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Duration of Response	NA Months

Secondary

Part D: Number of Participants With Positive Anti-TSR-042 Antibodies

Time frame: Up to 9.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants

Secondary

Part D: Objective Response Rate

Time frame: Up to 9.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Objective Response Rate	50.0 Percentage of participants

Secondary

Part D: Progression-free Survival

Time frame: Up to 9.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Progression-free Survival	7.6 Months

Secondary

Part D: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Tmax of TSR-042	1.250 Hours

Secondary

Part D: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Tmax,ss of TSR-042	Cycle 4, n=5	0.500 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Tmax,ss of TSR-042	Cycle 5, n=5	0.550 Hours
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Tmax,ss of TSR-042	Cycle 11, n=4	0.500 Hours

Secondary

Part D: Vss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vss of TSR-042	Cycle 4, n=5	5.1493 Liter	Standard Deviation 1.5834
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vss of TSR-042	Cycle 5, n=5	5.6399 Liter	Standard Deviation 1.41478
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vss of TSR-042	Cycle 11, n=3	8.0614 Liter	Standard Deviation 0.48037

Secondary

Part D: Vz of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)

Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).

Arm	Measure	Group	Value (MEAN)	Dispersion
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vz of TSR-042	Cycle 4, n=5	5.4955 Liter	Standard Deviation 1.89543
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vz of TSR-042	Cycle 5, n=5	6.1542 Liter	Standard Deviation 1.57345
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part D: Vz of TSR-042	Cycle 11, n=3	9.8356 Liter	Standard Deviation 0.99107
Unknown	Part D: Vz of TSR-042	Cycle 1, n=0	— Liter	—

Secondary

Part E: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part E: AUC0-t of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: AUC0-t of TSR-042	NA Hours*microgram per milliliter

Secondary

Part E: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: AUCss of TSR-042	NA Hours*microgram per milliliter

Secondary

Part E: CL of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: CL of TSR-042	NA Liter per hour

Secondary

Part E: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Cmax of TSR-042	NA Microgram per milliliter

Secondary

Part E: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Cmax,ss of TSR-042	NA Microgram per milliliter

Secondary

Part E: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Ctau of TSR-042	NA Microgram per milliliter

Secondary

Part E: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Ctau,ss of TSR-042	NA Microgram per milliliter

Secondary

Part E: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 4.4 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Disease Control Rate	0 Percentage of participants

Secondary

Part E: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 4.4 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Duration of Response	NA Months

Secondary

Part E: Number of Participants With Positive Anti-TSR-042 Antibodies

Time frame: Up to 4.4 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Number of Participants With Positive Anti-TSR-042 Antibodies	0 Participants

Secondary

Part E: Objective Response Rate

Time frame: Up to 4.4 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Objective Response Rate	0 Percentage of participants

Secondary

Part E: Progression-free Survival

Time frame: Up to 4.4 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Progression-free Survival	NA Months

Secondary

Part E: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Tmax of TSR-042	NA Hours

Secondary

Part E: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Tmax,ss of TSR-042	NA Hours

Secondary

Part E: Vss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Vss of TSR-042	NA Liter

Secondary

Part E: Vz of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part E: Vz of TSR-042	NA Liter

Secondary

Part F: AUC(0-infinity) of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUC(0-infinity) of TSR-022	NA Hours*microgram per milliliter

Secondary

Part F: AUC(0-infinity) of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (GEOMETRIC_MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUC(0-infinity) of TSR-042	NA Hours*microgram per milliliter

Secondary

Part F: AUC0-t of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUC0-t of TSR-022	NA Hours*microgram per milliliter

Secondary

Part F: AUC0-t of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUC0-t of TSR-042	NA Hours*microgram per milliliter

Secondary

Part F: AUCss of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUCss of TSR-022	NA Hours*microgram per milliliter

Secondary

Part F: AUCss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: AUCss of TSR-042	NA Hours*microgram per milliliter

Secondary

Part F: CL of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: CL of TSR-022	NA Liter per hour

Secondary

Part F: CL of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: CL of TSR-042	NA Liter per hour

Secondary

Part F: Cmax of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Cmax of TSR-022	NA Microgram per milliliter

Secondary

Part F: Cmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Cmax of TSR-042	NA Microgram per milliliter

Secondary

Part F: Cmax,ss of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Cmax,ss of TSR-022	NA Microgram per milliliter

Secondary

Part F: Cmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Cmax,ss of TSR-042	NA Microgram per milliliter

Secondary

Part F: Ctau of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Ctau of TSR-022	NA Microgram per milliliter

Secondary

Part F: Ctau of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Ctau of TSR-042	NA Microgram per milliliter

Secondary

Part F: Ctau,ss of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Ctau,ss of TSR-022	NA Microgram per milliliter

Secondary

Part F: Ctau,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Ctau,ss of TSR-042	NA Microgram per milliliter

Secondary

Part F: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 3.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Disease Control Rate	100 Percentage of participants

Secondary

Part F: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 3.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Duration of Response	NA Months

Secondary

Part F: Number of Participants With Positive Anti-TSR-022 Antibodies

Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 3.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With Positive Anti-TSR-022 Antibodies	NA Participants

Secondary

Part F: Number of Participants With Positive Anti-TSR-042 Antibodies

Time frame: Up to 3.5 months

Population: Anti-drug Antibody Population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Number of Participants With Positive Anti-TSR-042 Antibodies	NA Participants

Secondary

Part F: Objective Response Rate

Time frame: Up to 3.5 months

Population: Safety Population.

Arm	Measure	Value (NUMBER)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Objective Response Rate	0 Percentage of participants

Secondary

Part F: Progression-free Survival

Time frame: Up to 3.5 months

Population: Safety Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Progression-free Survival	NA Months

Secondary

Part F: Tmax of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Tmax of TSR-022	NA Hours

Secondary

Part F: Tmax of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Tmax of TSR-042	NA Hours

Secondary

Part F: Tmax,ss of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Tmax,ss of TSR-022	NA Hours

Secondary

Part F: Tmax,ss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEDIAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Tmax,ss of TSR-042	NA Hours

Secondary

Part F: Vss of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Vss of TSR-022	NA Liter

Secondary

Part F: Vss of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Vss of TSR-042	NA Liter

Secondary

Part F: Vz of TSR-022

Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Vz of TSR-022	NA Liter

Secondary

Part F: Vz of TSR-042

Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population.

Arm	Measure	Value (MEAN)
Main Study: Part A: TSR-042 and Niraparib 200 mg QD	Part F: Vz of TSR-042	NA Liter

Secondary

Part G: AUC(0-infinity) of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: AUC0-t of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: AUCss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: CL of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Cmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Cmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Ctau of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Ctau,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Number of Participants With Positive Anti-TSR-042 Antibodies

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Objective Response Rate

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Progression-free Survival

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Tmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Tmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Vss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part G: Vz of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part G.

Secondary

Part H: AUC(0-infinity) of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: AUC(0-infinity) of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: AUC0-t of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: AUC0-t of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: AUCss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: AUCss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: CL of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: CL of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Cmax of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Cmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Cmax,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Cmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Ctau of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Ctau of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Ctau,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Ctau,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Number of Participants With Positive Anti-TSR-022 Antibodies

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Number of Participants With Positive Anti-TSR-042 Antibodies

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Objective Response Rate

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Progression-free Survival

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Tmax of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Tmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Tmax,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Tmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Vss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Vss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Vz of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part H: Vz of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part H.

Secondary

Part I: AUC(0-infinity) of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: AUC(0-infinity) of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: AUC0-t of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: AUC0-t of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: AUCss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: AUCss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: CL of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: CL of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Cmax of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Cmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Cmax,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Cmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Ctau of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Ctau of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Ctau,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Ctau,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Disease Control Rate

Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Duration of Response

Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Number of Participants With Positive Anti-TSR-022 Antibodies

Time frame: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Number of Participants With Positive Anti-TSR-042 Antibodies

Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).

Time frame: Up to 24 months

Population: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Objective Response Rate

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Progression-free Survival

Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.

Time frame: Up to 24 months

Population: Safety Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Tmax of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Tmax of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Tmax,ss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Tmax,ss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Vss of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Vss of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Vz of TSR-022

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Secondary

Part I: Vz of TSR-042

Blood samples were planned to be collected at indicated time points.

Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)

Population: PK Population. Data was not collected as no participants were enrolled in Part I.

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Part A: Number of Participants With Dose-limiting Toxicity (DLT)

Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)

Part B: Number of Participants With DLT

Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part C: Number of Participants With DLT

Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part D: Number of Participants With DLT

Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part E: Number of Participants With DLT

Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part F: Number of Participants With DLT

Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part G: Number of Participants With DLT

Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part H: Number of Participants With DLT

Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part I: Number of Participants With DLT

Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs

Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib

Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib

Part A: AUC(0-infinity) of TSR-042

Part A: AUC(0-t) of TSR-042

Part A: AUC at Steady State (AUCss) of Niraparib

Part A: AUCss of TSR-042

Part A: Clearance After Intravenous Administration (CL) of TSR-042

Part A: Clearance After Oral Administration (CL/F) of Niraparib

Part A: Cmax at Steady State (Cmax,ss) of Niraparib

Part A: Cmax of TSR-042

Part A: Cmax,ss of TSR-042

Part A: Ctau at Steady State (Ctau,ss) of Niraparib

Part A: Ctau of TSR-042

Part A: Ctau,ss of TSR-042

Part A: Disease Control Rate

Part A: Duration of Response

Part A: Maximum Observed Plasma (Cmax) of Niraparib

Part A: Number of Participants With Positive Anti-TSR-042 Antibodies

Part A: Objective Response Rate

Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib

Part A: Progression-free Survival

Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib

Part A: Tmax at Steady State (Tmax,ss) of Niraparib

Part A: Tmax of TSR-042

Part A: Tmax,ss of TSR-042

Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042

Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042

Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib

Part B: AUC(0-infinity) of TSR-042

Part B: AUC0-t of TSR-042

Part B: AUCss of TSR-042

Part B: CL of TSR-042

Part B: Cmax of TSR-042

Part B: Cmax,ss of TSR-042

Part B: Ctau of TSR-042

Part B: Ctau,ss of TSR-042

Part B: Disease Control Rate

Part B: Duration of Response

Part B: Number of Participants With Positive Anti-TSR-042 Antibodies

Part B: Objective Response Rate