Castration-resistant Prostate Cancer, Colorectal Cancer, Cutaneous Squamous Cell Carcinoma, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Ovarian Cancer
Conditions
Keywords
SOT101, SO-C101, Pembrolizumab, Non-Small Cell Lung Cancer, Colorectal Cancer, Cutaneous Squamous Cell Carcinoma, Advanced Hepatocellular Carcinoma, Metastatic Castration-resistant Prostate Cancer, Ovarian Cancer, KEYNOTE-D13, AURELIO-04, Nanrilkefusp Alfa
Brief summary
The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.
Interventions
Subcutaneous (SC) injection.
DRUGPembrolizumab
Intravenous (IV) infusion via peripheral or central venous line.
Sponsors
Merck Sharp & Dohme LLC
SOTIO Biotech AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with the following histologically or cytologically confirmed solid tumor indications and line of treatment: 1. Non-small cell lung cancer (NSCLC). 2. Colorectal cancer. 3. Cutaneous squamous cell carcinoma (cSCC). 4. Advanced hepatocellular carcinoma (not applicable in France). 5. mCRPC. 6. Ovarian cancer. * Have measurable disease per RECIST 1.1. mCRPC participants with no measurable disease and only widespread bone disease must have a CTC count of ≥5 cells per 7.5 mL of blood. * Availability of tumor tissue from a fresh biopsy at screening unless the biopsy cannot be obtained due to safety reasons or non-accessibility of the tumor site. If it is not possible to obtain a fresh biopsy, every effort should be taken to retrieve an archival biopsy. Archived, fixed tumor tissue may only be collected if taken preferentially after completion of the most recent systemic tumor therapy and within 12 months prior to the first dose of study treatment. * Eastern Cooperative Oncology Group (ECOG) score 0-1. * Have recovered from all AEs (except alopecia) due to previous therapies to grade ≤1 (excluding alopecia) or have stable grade 2 neuropathy. * Have adequate organ function as defined below: 1. Hematology: 1. Absolute neutrophil count ≥1500/μL. 2. Platelets ≥100 000/μL. 3. Hemoglobin ≥9.0 g/dL . 2. Renal function: Creatinine clearance as measured by glomerular filtration rate ≥30 mL/min using Cockcroft-Gault equation. 3. Hepatic function: Alanine transaminase (ALT)/aspartate transaminase (AST) ≤2.5× upper limit of normal (ULN) and total bilirubin ≤1.5×ULN or direct bilirubin ≤ ULN in participants without liver metastasis. In participants with liver metastasis, ALT/AST ≤5×ULN is allowed but total bilirubin must be ≤2×ULN. 4. Prothrombin time and activated partial thromboplastin time ≤1.5×ULN. * Participants must not have active hepatitis B or hepatitis C infection. * Adequate contraception must be applied in all women of childbearing potential (WOCBP) and in male participants.
Exclusion criteria
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and was discontinued from that treatment due to a grade ≥3 AE. * Prior exposure to agonists of interleukin (IL)-2 or IL-15. * Prior systemic anti-cancer therapies, including investigational agents: 1. Less than 4 weeks for systemic chemotherapy and immuno-oncology therapies; and for tyrosine kinase inhibitors 4 weeks or 5 half-lives (whichever is shorter). 2. Less than 4 weeks from major surgeries and not recovered adequately. * Has received prior radiotherapy within 2 weeks of the start of study interventions or have had a history of radiation pneumonitis. * NSCLC indication only: Received radiation therapy to the lung \>30 Gy within 6 months. * Has received a live or live-attenuated vaccine within 30 days. * Clinically significant cardiac abnormalities including prior history of any of the following: 1. Cardiomyopathy, with left ventricular ejection fraction ≤ 50%. 2. Congestive heart failure of New York Heart Association grade ≥2. 3. History of clinically significant artery or coronary heart disease. 4. Prolongation of QTcF \>450 msec . 5. Clinically significant cardiac arrythmia that cannot be controlled with adequate medication. * Uncontrolled hypertension defined as systolic blood pressure \>160 mmHg, diastolic blood pressure \>110 mmHg. * Prior allogeneic hematopoietic stem cell transplantation within the last 5 years. * Prior allogeneic tissue/solid organ transplant. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy. * History of or serology positive for human immunodeficiency virus (HIV). * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ that have undergone potentially curative therapy are not excluded. * Has known active central nervous system metastases and/or carcinomatous meningitis, unless stable. * Had severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has any condition that might confound the results of the study or interfere with the participant's participation for the full duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | Day 1 up to approximately 2 years and 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients With a Treatment-emergent Adverse Event | Day 1 up to approximately 2 years and 2 months |
| Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to iRECIST: Complete Response | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to iRECIST: Partial Response | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to iRECIST: Stable Disease | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | Day 1 up to approximately 2 years and 2 months |
| Duration of Response According to RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Duration of Response According to iRECIST | Day 1 up to approximately 2 years and 2 months |
| Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Number of Patients With an Adverse Event of Special Interest | Day 1 up to approximately 2 years and 2 months |
| Progression-free Survival According to RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Progression-free Survival According to iRECIST | Day 1 up to approximately 2 years and 2 months |
| Time to Response According to RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Time to Response According to iRECIST | Day 1 up to approximately 2 years and 2 months |
| Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years and 2 months |
| Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years |
| Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years |
| Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | Day 1 up to approximately 2 years |
| Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration |
| Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration |
| Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | Cycle 4 Day 1, approximately 9 weeks |
| Percentage of Patients With Clinical Benefit Rate According to iRECIST | Day 1 up to approximately 2 years and 2 months |
Countries
Belgium, Czechia, France, Georgia, Hungary, Italy, Poland, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-small Cell Lung Cancer Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment | 40 |
| Colorectal Cancer Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic | 8 |
| Cutaneous Squamous Cell Carcinoma Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible | 12 |
| Hepatocellular Carcinoma Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France) | 12 |
| Metastatic Castration-resistant Prostate Cancer Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent | 54 |
| Ovarian Cancer Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months | 39 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 17 | 3 | 4 | 5 | 24 | 21 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other, not specified | 0 | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 2 | 0 |
| Overall Study | Study terminated by sponsor | 18 | 5 | 5 | 5 | 18 | 11 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 2 | 2 | 8 | 6 |
Baseline characteristics
| Characteristic | Cutaneous Squamous Cell Carcinoma | Non-small Cell Lung Cancer | Colorectal Cancer | Hepatocellular Carcinoma | Metastatic Castration-resistant Prostate Cancer | Ovarian Cancer | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 17 Participants | 3 Participants | 4 Participants | 40 Participants | 18 Participants | 93 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 23 Participants | 5 Participants | 8 Participants | 14 Participants | 21 Participants | 72 Participants |
| Age, Continuous | 75.5 years STANDARD_DEVIATION 10.95 | 63.5 years STANDARD_DEVIATION 10.43 | 59.0 years STANDARD_DEVIATION 18.34 | 63.5 years STANDARD_DEVIATION 11.02 | 68.0 years STANDARD_DEVIATION 6.57 | 64.0 years STANDARD_DEVIATION 11.59 | 66.0 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 30 Participants | 6 Participants | 12 Participants | 48 Participants | 35 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 1 Participants | 0 Participants | 5 Participants | 4 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 1 Participants | 0 Participants | 4 Participants | 3 Participants | 19 Participants |
| Race (NIH/OMB) White | 9 Participants | 32 Participants | 7 Participants | 12 Participants | 49 Participants | 36 Participants | 145 Participants |
| Region of Enrollment Belgium | 0 participants | 6 participants | 0 participants | 4 participants | 1 participants | 8 participants | 19 participants |
| Region of Enrollment Czechia | 0 participants | 2 participants | 1 participants | 0 participants | 2 participants | 3 participants | 8 participants |
| Region of Enrollment France | 3 participants | 8 participants | 1 participants | 0 participants | 4 participants | 5 participants | 21 participants |
| Region of Enrollment Georgia | 6 participants | 13 participants | 4 participants | 8 participants | 19 participants | 6 participants | 56 participants |
| Region of Enrollment Hungary | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Italy | 2 participants | 4 participants | 0 participants | 0 participants | 2 participants | 0 participants | 8 participants |
| Region of Enrollment Poland | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 2 participants |
| Region of Enrollment Spain | 1 participants | 6 participants | 1 participants | 0 participants | 21 participants | 16 participants | 45 participants |
| Region of Enrollment United States | 0 participants | 1 participants | 0 participants | 0 participants | 2 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 12 Participants | 3 Participants | 1 Participants | 0 Participants | 39 Participants | 57 Participants |
| Sex: Female, Male Male | 10 Participants | 28 Participants | 5 Participants | 11 Participants | 54 Participants | 0 Participants | 108 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 17 / 40 | 3 / 8 | 4 / 12 | 5 / 12 | 24 / 55 | 21 / 39 |
| other Total, other adverse events | 40 / 40 | 8 / 8 | 12 / 12 | 12 / 12 | 54 / 54 | 39 / 39 |
| serious Total, serious adverse events | 23 / 40 | 3 / 8 | 3 / 12 | 3 / 12 | 28 / 54 | 28 / 39 |
Outcome results
Primary
Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 5.1 percentage of participants |
| Colorectal Cancer | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 33.3 percentage of participants |
| Cutaneous Squamous Cell Carcinoma | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 27.3 percentage of participants |
| Hepatocellular Carcinoma | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 0 percentage of participants |
| Metastatic Castration-resistant Prostate Cancer | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 10.0 percentage of participants |
| Ovarian Cancer | Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) | 11.4 percentage of participants |
Secondary
Duration of Response According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Duration of Response According to iRECIST | 3.6 months |
| Colorectal Cancer | Duration of Response According to iRECIST | NA months |
| Cutaneous Squamous Cell Carcinoma | Duration of Response According to iRECIST | NA months |
| Hepatocellular Carcinoma | Duration of Response According to iRECIST | NA months |
| Metastatic Castration-resistant Prostate Cancer | Duration of Response According to iRECIST | 13.9 months |
| Ovarian Cancer | Duration of Response According to iRECIST | 3.0 months |
Secondary
Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | NA months |
Secondary
Duration of Response According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Duration of Response According to RECIST 1.1 | 3.6 months |
| Colorectal Cancer | Duration of Response According to RECIST 1.1 | NA months |
| Cutaneous Squamous Cell Carcinoma | Duration of Response According to RECIST 1.1 | NA months |
| Hepatocellular Carcinoma | Duration of Response According to RECIST 1.1 | NA months |
| Metastatic Castration-resistant Prostate Cancer | Duration of Response According to RECIST 1.1 | NA months |
| Ovarian Cancer | Duration of Response According to RECIST 1.1 | 3.0 months |
Secondary
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration
Time frame: Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 3.6800 ng/mL |
| Colorectal Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 3.6700 ng/mL |
| Cutaneous Squamous Cell Carcinoma | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 3.4250 ng/mL |
| Hepatocellular Carcinoma | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 2.5600 ng/mL |
| Metastatic Castration-resistant Prostate Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 3.4500 ng/mL |
| Ovarian Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration | 3.1300 ng/mL |
Secondary
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration
Time frame: Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 1.0900 ng/mL |
| Colorectal Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 0.5890 ng/mL |
| Cutaneous Squamous Cell Carcinoma | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 0.7200 ng/mL |
| Hepatocellular Carcinoma | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 0.9470 ng/mL |
| Metastatic Castration-resistant Prostate Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 0 ng/mL |
| Ovarian Cancer | Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration | 0.9020 ng/mL |
Secondary
Number of Patients With an Adverse Event of Special Interest
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With an Adverse Event of Special Interest | 0 Participants |
| Colorectal Cancer | Number of Patients With an Adverse Event of Special Interest | 1 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With an Adverse Event of Special Interest | 0 Participants |
| Hepatocellular Carcinoma | Number of Patients With an Adverse Event of Special Interest | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With an Adverse Event of Special Interest | 0 Participants |
| Ovarian Cancer | Number of Patients With an Adverse Event of Special Interest | 0 Participants |
Secondary
Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1
Time frame: Cycle 4 Day 1, approximately 9 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 5 Participants |
| Colorectal Cancer | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 3 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 3 Participants |
| Hepatocellular Carcinoma | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 4 Participants |
| Ovarian Cancer | Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1 | 5 Participants |
Secondary
Number of Patients With a Treatment-emergent Adverse Event
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With a Treatment-emergent Adverse Event | 40 Participants |
| Colorectal Cancer | Number of Patients With a Treatment-emergent Adverse Event | 8 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With a Treatment-emergent Adverse Event | 12 Participants |
| Hepatocellular Carcinoma | Number of Patients With a Treatment-emergent Adverse Event | 12 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With a Treatment-emergent Adverse Event | 54 Participants |
| Ovarian Cancer | Number of Patients With a Treatment-emergent Adverse Event | 39 Participants |
Secondary
Number of Patients With Best Overall Response According to iRECIST: Complete Response
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 0 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 0 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 1 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 0 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to iRECIST: Complete Response | 0 Participants |
Secondary
Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 3 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 1 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 2 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 1 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 2 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease | 8 Participants |
Secondary
Number of Patients With Best Overall Response According to iRECIST: Partial Response
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 3 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 2 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 3 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 5 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to iRECIST: Partial Response | 4 Participants |
Secondary
Number of Patients With Best Overall Response According to iRECIST: Stable Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 15 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 3 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 2 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 5 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 15 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to iRECIST: Stable Disease | 4 Participants |
Secondary
Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 13 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 0 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 3 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 4 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 14 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease | 15 Participants |
Secondary
Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 0 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 0 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 1 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 0 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response | 0 Participants |
Secondary
Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 2 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 2 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 2 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 0 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 4 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response | 4 Participants |
Secondary
Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 20 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 1 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 6 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 5 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 18 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease | 23 Participants |
Secondary
Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-small Cell Lung Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 12 Participants |
| Colorectal Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 3 Participants |
| Cutaneous Squamous Cell Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 2 Participants |
| Hepatocellular Carcinoma | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 5 Participants |
| Metastatic Castration-resistant Prostate Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 14 Participants |
| Ovarian Cancer | Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease | 4 Participants |
Secondary
Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | 3.8 percentage of participants |
Secondary
Percentage of Patients With Clinical Benefit Rate According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 46.2 percentage of participants |
| Colorectal Cancer | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 83.3 percentage of participants |
| Cutaneous Squamous Cell Carcinoma | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 54.5 percentage of participants |
| Hepatocellular Carcinoma | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 45.5 percentage of participants |
| Metastatic Castration-resistant Prostate Cancer | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 50.0 percentage of participants |
| Ovarian Cancer | Percentage of Patients With Clinical Benefit Rate According to iRECIST | 22.9 percentage of participants |
Secondary
Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | 45.0 percentage of participants |
Secondary
Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 35.9 percentage of participants |
| Colorectal Cancer | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 83.3 percentage of participants |
| Cutaneous Squamous Cell Carcinoma | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 45.5 percentage of participants |
| Hepatocellular Carcinoma | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 45.5 percentage of participants |
| Metastatic Castration-resistant Prostate Cancer | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 45.0 percentage of participants |
| Ovarian Cancer | Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1 | 22.9 percentage of participants |
Secondary
Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | 13.5 percentage of participants |
Secondary
Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
Time frame: Day 1 up to approximately 2 years and 2 months
Population: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-small Cell Lung Cancer | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 7.7 percentage of participants |
| Colorectal Cancer | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 33.3 percentage of participants |
| Cutaneous Squamous Cell Carcinoma | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 36.4 percentage of participants |
| Hepatocellular Carcinoma | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 0 percentage of participants |
| Metastatic Castration-resistant Prostate Cancer | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 12.5 percentage of participants |
| Ovarian Cancer | Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST) | 11.4 percentage of participants |
Secondary
Progression-free Survival According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Progression-free Survival According to iRECIST | 3.0 months |
| Colorectal Cancer | Progression-free Survival According to iRECIST | NA months |
| Cutaneous Squamous Cell Carcinoma | Progression-free Survival According to iRECIST | 4.1 months |
| Hepatocellular Carcinoma | Progression-free Survival According to iRECIST | 2.7 months |
| Metastatic Castration-resistant Prostate Cancer | Progression-free Survival According to iRECIST | 4.6 months |
| Ovarian Cancer | Progression-free Survival According to iRECIST | 1.6 months |
Secondary
Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | 2.6 months |
Secondary
Progression-free Survival According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Progression-free Survival According to RECIST 1.1 | 1.6 months |
| Colorectal Cancer | Progression-free Survival According to RECIST 1.1 | NA months |
| Cutaneous Squamous Cell Carcinoma | Progression-free Survival According to RECIST 1.1 | 1.4 months |
| Hepatocellular Carcinoma | Progression-free Survival According to RECIST 1.1 | 2.7 months |
| Metastatic Castration-resistant Prostate Cancer | Progression-free Survival According to RECIST 1.1 | 2.6 months |
| Ovarian Cancer | Progression-free Survival According to RECIST 1.1 | 1.6 months |
Secondary
Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
Time frame: Day 1 up to approximately 2 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1 | 2.3 months |
Secondary
Time to Response According to iRECIST
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Time to Response According to iRECIST | NA months |
| Colorectal Cancer | Time to Response According to iRECIST | 14.1 months |
| Cutaneous Squamous Cell Carcinoma | Time to Response According to iRECIST | NA months |
| Hepatocellular Carcinoma | Time to Response According to iRECIST | NA months |
| Metastatic Castration-resistant Prostate Cancer | Time to Response According to iRECIST | NA months |
| Ovarian Cancer | Time to Response According to iRECIST | NA months |
Secondary
Time to Response According to RECIST 1.1
Time frame: Day 1 up to approximately 2 years and 2 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Non-small Cell Lung Cancer | Time to Response According to RECIST 1.1 | NA months |
| Colorectal Cancer | Time to Response According to RECIST 1.1 | 14.1 months |
| Cutaneous Squamous Cell Carcinoma | Time to Response According to RECIST 1.1 | NA months |
| Hepatocellular Carcinoma | Time to Response According to RECIST 1.1 | NA months |
| Metastatic Castration-resistant Prostate Cancer | Time to Response According to RECIST 1.1 | NA months |
| Ovarian Cancer | Time to Response According to RECIST 1.1 | NA months |