Locally Advanced and Metastatic Solid Tumors
Conditions
Keywords
BGB-A1217, Anti-TIGIT antibody, Tislelizumab, anti-PD-1 antibody, Ociperlimab
Brief summary
The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
Interventions
DRUGOciperlimab
Administered as an intravenous (IV) injection
DRUGTislelizumab
Administered as an IV injection
DRUGPemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product
DRUGPaclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGNab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGCarboplatin
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGCisplatin
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGEtoposide
Administered in accordance with local guidelines , prescribing information/summary of product
DRUG5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGOxaliplatin
Administered in accordance with local guidelines , prescribing information/summary of product
DRUGCapecitabine
Administered in accordance with local guidelines , prescribing information/summary of product
Sponsors
BeiGene
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
No
Inclusion criteria
Key Inclusion Criteria: Phase 1 Key Inclusion Criteria 1. Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1. 2. Greater than or equal to (\>=) measurable lesion per RECIST v1.1. 3. Had adequate organ function. 4. Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused. Phase 1b Key Inclusion Criteria 1. Signed informed consent form (ICF) and able to comply with study requirements. 2. Age \>= 18 years (or the legal age of consent) at the time the ICF was signed. 3. Histologically or cytologically confirmed tumor types in the following disease cohorts: Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive. 4. ECOG Performance Status \<= 1 5. Adequate organ function 6. Were willing to use highly effective method of birth control Phase 1 Key
Exclusion criteria
1. Active brain or leptomeningeal metastasis. 2. Active autoimmune diseases or history of autoimmune diseases that could have relapsed. 3. Had severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma). 4. Concurrent participation in another therapeutic clinical trial. 5. Received prior therapies targeting TIGIT. Phase 1b Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab | up to 28 days (Dose escalation cohorts) | RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts. |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts]) | An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE. |
| Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts) | The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, \>= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or \<=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting \> 7 days; \>=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting \> 7 days; \>=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab. |
| Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab | Up to 28 days (Dose escalation cohort) | MAD was defined as the highest dose of ociperlimab administered. |
| Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10) | ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days) | Serum concentration of ociperlimab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. C in the timeframe below refers to Cycle and D refers to Day and h refers to hours. |
| Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days) | Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion. |
| Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Up to 32.2 months (Dose escalation cohorts) and up to 11 months (Dose verification cohorts) | Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration. |
| Phase 1b: DOR as Per RECIST v.1.1 | From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10]) | DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. |
| Phase 1b: DCR as Per RECIST v.1.1 | From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10]) | DCR was defined as the percentage of participants with BOR, as per RECIST v.1.1, of a CR, PR, or SD. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | From first dose of study drugs to the date of the first documentation of PD or death, whichever came first (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10]) | PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. |
| Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Up to 30 days after the last dose of study interventions (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10]) | An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE. |
| Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days) | Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion. |
| Phase 1: ORR as Per RECIST v.1.1 | Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts) | ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Pre-dose, post-dose, 168 h, 336 h post-dose Cycle1 Day 1, Pre-dose on Cycle 2 Day 1, Pre-dose, post-dose (30 min) on Cycle 5 Day 1, Pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, and Cycle 25 Day 1 (each cycle = 21 days) | Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion and 'h' in the time-frame section refers to hours. |
| Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1 (pre-dose and post-dose, Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days) | Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion. |
| Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Up to 34.4 months (Cohorts 1 to 9) and up to 20.8 months (Cohort 10) | Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration. |
| Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10) | Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells (IC) and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. ORR is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7. |
| Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10) | Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. ORR is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7. |
| Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10) | Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. Median PFS (mPFS) is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7. |
| Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10) | Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. mPFS is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7. |
| Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1 (pre-dose and post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days) | Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion. |
| Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 | From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts]) | DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. |
| Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts]) | DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days) | Serum concentrations of ociperlimab were measured. Post-dose refers to the data collected for 30 minutes post-infusion. C in the timeframe below refers to Cycle and D refers to Day and h refers to hours. |
| Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days) | Serum Concentrations of Tislelizumab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. |
Countries
Australia, China, New Zealand, South Korea, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg Participants received ociperlimab 50 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e., Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 1 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 3 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 6 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 16 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 6 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 9 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) Participants received ociperlimab 900 mg IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. | 11 |
| Phase 1b: Dose Expansion: Cohort 1 Participants with metastatic squamous NSCLC received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemo with carboplatin AUC 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W until disease progression, intolerable toxicity, or withdrawal of consent. | 41 |
| Phase 1b: Dose Expansion: Cohort 2 Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W until disease progression, intolerable toxicity, or withdrawal of consent. | 43 |
| Phase 1b: Dose Expansion: Cohort 3 Participants with metastatic NSCLC (PD-L1 positive, TC \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 45 |
| Phase 1b: Dose Expansion: Cohort 4 Participants with extensive-stage SCLC received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 /carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, intolerable toxicity, or withdrawal of consent. | 43 |
| Phase 1b: Dose Expansion: Cohort 5 Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 26 |
| Phase 1b: Dose Expansion: Cohort 6 Participants with metastatic ESCC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle and were followed up until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. | 21 |
| Phase 1b: Dose Expansion: Cohort 7 Participants with metastatic EAC received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 6 |
| Phase 1b: Dose Expansion: Cohort 8 Participants with recurrent or metastatic HNSCC; PD-L1 positive, vCPS \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 41 |
| Phase 1b: Dose Expansion: Cohort 9 Participants with unresectable, locally advanced, recurrent, or metastatic G/GEJ adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\], or cisplatin 75 mg/m\^2 \[Day 1\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, intolerable toxicity, or withdrawal of consent. | 60 |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 24 |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 21 |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, or withdrawal of consent. | 23 |
| Total | 446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Completed all Assessments | 1 | 3 | 1 | 3 | 2 | 5 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 4 | 7 | 2 | 4 | 3 | 24 | 24 | 22 | 35 | 18 | 14 | 6 | 19 | 42 | 9 | 8 | 10 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 3 | 0 | 0 | 2 | 2 | 1 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 10 | 18 | 3 | 3 | 4 | 0 | 7 | 8 | 9 | 7 | 8 |
| Overall Study | Transfer to a Company Sponsored Clinical Trial | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 5 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 2 | 2 | 2 |
| Overall Study | Transfer to Patient Supply Treatment Program (PTS) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 5 | 2 | 0 | 1 | 0 | 4 | 4 | 4 | 2 | 3 | 0 | 9 | 5 | 1 | 3 | 1 |
Baseline characteristics
| Characteristic | Phase 1b: Dose Expansion: Cohort 4 | Phase 1b: Dose Expansion: Cohort 5 | Phase 1b: Dose Expansion: Cohort 9 | Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b: Dose Expansion: Cohort 8 | Phase 1b: Dose Expansion: Cohort 1 | Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b: Dose Expansion: Cohort 7 | Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Total | Phase 1b: Dose Expansion: Cohort 6 | Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: Dose Expansion: Cohort 2 | Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b: Dose Expansion: Cohort 3 | Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 9.79 | 66.7 years STANDARD_DEVIATION 9.34 | 60.1 years STANDARD_DEVIATION 11.65 | 48.7 years STANDARD_DEVIATION 18.9 | 63.5 years STANDARD_DEVIATION 10.74 | 64.9 years STANDARD_DEVIATION 8.04 | 50.0 years | 63.0 years STANDARD_DEVIATION 4.24 | 61.9 years STANDARD_DEVIATION 7.66 | 62.8 years STANDARD_DEVIATION 10.03 | 62.2 years STANDARD_DEVIATION 6.02 | 56.8 years STANDARD_DEVIATION 11.25 | 64.0 years STANDARD_DEVIATION 7.05 | 62.7 years STANDARD_DEVIATION 8.71 | 60.4 years STANDARD_DEVIATION 11.45 | 67.0 years STANDARD_DEVIATION 6.9 | 61.5 years STANDARD_DEVIATION 10.46 | 53.3 years STANDARD_DEVIATION 14.75 | 65.4 years STANDARD_DEVIATION 8.59 | 65.4 years STANDARD_DEVIATION 8.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 26 Participants | 58 Participants | 3 Participants | 41 Participants | 41 Participants | 1 Participants | 6 Participants | 9 Participants | 441 Participants | 21 Participants | 6 Participants | 20 Participants | 43 Participants | 11 Participants | 6 Participants | 24 Participants | 16 Participants | 44 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 32 Participants | 11 Participants | 46 Participants | 0 Participants | 37 Participants | 38 Participants | 0 Participants | 0 Participants | 9 Participants | 333 Participants | 16 Participants | 2 Participants | 19 Participants | 35 Participants | 11 Participants | 1 Participants | 22 Participants | 3 Participants | 34 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported/Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 8 Participants | 15 Participants | 11 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 6 Participants | 0 Participants | 95 Participants | 2 Participants | 4 Participants | 2 Participants | 7 Participants | 0 Participants | 4 Participants | 1 Participants | 13 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 16 Participants | 1 Participants | 6 Participants | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 116 Participants | 3 Participants | 4 Participants | 4 Participants | 12 Participants | 1 Participants | 2 Participants | 7 Participants | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 32 Participants | 18 Participants | 44 Participants | 2 Participants | 35 Participants | 35 Participants | 1 Participants | 6 Participants | 6 Participants | 330 Participants | 18 Participants | 2 Participants | 17 Participants | 31 Participants | 10 Participants | 4 Participants | 17 Participants | 6 Participants | 29 Participants | 17 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 | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 | 4 / 6 | 7 / 16 | 2 / 6 | 4 / 9 | 3 / 11 | 24 / 41 | 24 / 43 | 22 / 45 | 35 / 43 | 18 / 26 | 14 / 21 | 6 / 6 | 19 / 41 | 42 / 60 | 8 / 21 | 9 / 24 | 10 / 23 |
| other Total, other adverse events | 1 / 1 | 3 / 3 | 6 / 6 | 13 / 16 | 6 / 6 | 8 / 9 | 11 / 11 | 40 / 41 | 42 / 43 | 44 / 45 | 41 / 43 | 24 / 26 | 21 / 21 | 6 / 6 | 39 / 41 | 59 / 60 | 17 / 21 | 22 / 24 | 23 / 23 |
| serious Total, serious adverse events | 1 / 1 | 2 / 3 | 3 / 6 | 9 / 16 | 1 / 6 | 3 / 9 | 5 / 11 | 21 / 41 | 28 / 43 | 15 / 45 | 23 / 43 | 9 / 26 | 11 / 21 | 4 / 6 | 22 / 41 | 32 / 60 | 8 / 21 | 10 / 24 | 13 / 23 |
Outcome results
Primary
Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Population: Analysis was performed on efficacy evaluable analysis set that included all treated participants who had measurable disease at baseline and \>= 1 evaluable postbaseline tumor response assessment unless discontinued from any component of study treatment due to clinical progression of disease (PD) or death within 7 weeks after first dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 55 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 54.8 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 40.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 65.9 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 7.7 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 68.4 percentage of participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 33.3 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 33.3 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 50.8 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 34.8 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 26.3 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 | 34.8 percentage of participants |
Primary
Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab
MAD was defined as the highest dose of ociperlimab administered.
Time frame: Up to 28 days (Dose escalation cohort)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab | 1800 milligram (mg) |
Primary
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, \>= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or \<=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting \> 7 days; \>=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting \> 7 days; \>=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab.
Time frame: Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Primary
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Time frame: Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Population: Analysis was performed on the safety analysis set that included all participants who received \>= 1 dose of any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 3 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 3 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 6 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 4 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 11 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 15 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 9 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 6 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 1 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 9 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 3 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 4 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Serious TEAE | 5 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with >= Grade 3 TEAE | 5 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Participants with any TEAE | 11 Participants |
Primary
Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab
RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.
Time frame: up to 28 days (Dose escalation cohorts)
Population: Analysis was performed on the safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab | 900 mg |
Secondary
Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion and 'h' in the time-frame section refers to hours.
Time frame: Pre-dose, post-dose, 168 h, 336 h post-dose Cycle1 Day 1, Pre-dose on Cycle 2 Day 1, Pre-dose, post-dose (30 min) on Cycle 5 Day 1, Pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, and Cycle 25 Day 1 (each cycle = 21 days)
Population: Analysis was performed on PK analysis set. Here, 'number analyzed' = participants with available data for the analysis of serum concentrations and 0 in the number analyzed signifies that no participant with available data at the specified time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 52.56 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 22 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 13.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 66 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 44.61 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 40.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 54 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 25.65 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 41 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 55.13 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 31 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 108.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 27.74 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 331 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 61.11 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 41 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 217.47 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 147.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 86.89 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 105.58 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 309.74 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 15 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 99.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 25 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 56.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 49 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 31.60 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 49 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 67.49 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 49 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 404.63 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 68.08 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 54 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 86.59 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 95 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 95.90 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 82 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 89.60 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 166 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 664.37 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 125.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 142.18 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 36 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 178.34 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 26 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 110.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 103.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 31 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 580.37 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 15 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 119.15 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 64.10 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 33 |
Secondary
Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Time frame: Cycle 1 Day 1 (pre-dose and post-dose, Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Population: Analysis was performed on PK analysis set. Here, 'number analyzed' = participants with available data for the analysis of serum concentrations and 0 in the number analyzed signifies that no participant with available data at the specified time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 53.01 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 13.81 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 59.21 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 73.38 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 117.14 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 36.10 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 43 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 68.42 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 34.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 80 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 82.30 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 14.87 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 31 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 35.56 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 103.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 35.17 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 48.07 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 64 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 42.67 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 36 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 55.86 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 18 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 2.94 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 317 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 67.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 12 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 28.70 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 39 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 14.70 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 90.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 17 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 32.80 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 63.62 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 17 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 25.24 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 52 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 37.52 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 25.96 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 110 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 29.99 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 40 |
Secondary
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Time frame: Up to 34.4 months (Cohorts 1 to 9) and up to 20.8 months (Cohort 10)
Population: Analysis was performed on ADA Analysis set. Here, number analyzed = participants with available data for ADA analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 24 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 22 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 16 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 17 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 17 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 16 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 11 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 12 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 3 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 3 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 11 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 11 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 2 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 2 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 9 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 10 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 17 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 17 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 1 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 9 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 11 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 2 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 6 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 5 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 9 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab NAb positive | 1 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab NAb positive | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 9 Participants |
Secondary
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. ORR is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Population: Analysis was performed on efficacy evaluable analysis set for participants with available PD-L1 expression levels. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed defines no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 1% | 66.7 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 1% | 56.3 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 1% | 60.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 1% | 42.9 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 50% | 30.8 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 50% | 52.6 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP >= 1% | 50.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP < 1% | 56.3 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 50% | 0.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 50% | 20.0 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP < 10% | 61.5 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP >= 10% | 100.0 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP >= 10% | 38.1 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP < 10% | 31.3 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP < 5% | 50.0 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TAP >= 5% | 55.6 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 50% | 12.5 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 50% | 46.7 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 50% | 18.2 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 50% | 37.5 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC >= 50% | 50.0 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression | ORR: PD-L1 TC < 50% | 26.7 percentage of participants |
Secondary
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells (IC) and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. ORR is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Population: Analysis was performed on efficacy evaluable analysis set for participants with available TIGIT or PD-L1 expression levels. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed defines no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 61.5 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 54.5 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 66.7 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 38.5 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 17.6 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 55.6 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 1% | 58.3 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 1% | 57.1 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 12.5 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 0.0 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 62.5 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 70.0 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 32.1 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 36.4 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 5% | 44.8 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 5% | 56.0 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 1% | 22.2 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 1% | 38.5 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 1% | 42.9 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 1% | 16.7 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC < 1% | 22.2 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression | ORR: TIGIT IC >= 1% | 38.5 percentage of participants |
Secondary
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows: For Cohort 1 and Cohort 2, PD-L1 TC \<1% or \>= 1%; for Cohorts 3, 5, and 10, PD-L1 TC \< 50% or \>=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) \<1% or \>=1%; for Cohort 9, PD-L1 TAP \< 5% or \>= 5%; for Cohort 6 and 8, PD-L1 TAP \<10% or \>=10%. mPFS is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Population: Analysis was performed on efficacy evaluable analysis set. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed defines no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 1% | 7.0 months |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 1% | 6.9 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 1% | 23.6 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 1% | 8.0 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 50% | 5.2 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 50% | 8.2 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP >= 1% | 5.4 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP < 1% | 5.1 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 50% | 1.6 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 50% | 20.6 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP < 10% | 7.6 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP >= 10% | 10.3 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP >= 10% | 7.1 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP < 10% | 4.0 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP < 5% | 6.7 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TAP >= 5% | 8.2 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 50% | 2.6 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 50% | 6.4 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 50% | 1.4 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 50% | 9.0 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC >= 50% | 6.8 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression | mPFS: PD-L1 TC < 50% | 8.5 months |
Secondary
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The TIGIT expression on immune cells and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as \<1% or \>=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as \<5% or \>=5%. Median PFS (mPFS) is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Population: Analysis was performed on efficacy evaluable analysis set. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed defines no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 6.9 months |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 7.0 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 12.6 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 10.9 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 5.5 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 5.4 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 1% | 5.1 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 1% | 4.9 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 5.2 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 3.8 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 7.9 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 8.1 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 6.1 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 4.1 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 5% | 6.9 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 5% | 8.2 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 1% | 2.7 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 1% | 2.8 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 1% | 1.6 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 1% | 9.0 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC < 1% | 5.5 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression | mPFS: TIGIT IC >= 1% | 8.5 months |
Secondary
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Time frame: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Population: Analysis was performed on PK analysis set. Here, Overall number of participants analyzed = participants with available data for this outcome measure and 'number analyzed' = the number of participants with available data for the analysis of serum concentrations and 0 in the number analyzed signifies no participant with available data at specified time-points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 293.20 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 102.28 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 78.12 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 68 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 77.56 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 51 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 70.55 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 50 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 386.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 25 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 89.49 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 32.06 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 51 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 98.90 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 35.93 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 62 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 88.71 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 60 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 112.33 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 66 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 80.94 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 75 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 120.07 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 37 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 296.90 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 103.40 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 61 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 111.36 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 43 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 382.09 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 65.66 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 64 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 78.16 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 44 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 354.15 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 287.70 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 68.12 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 59 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 91.84 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 39 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 32.63 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 55 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 85.34 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 47 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 90.14 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 344.61 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 77.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 47 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 282.22 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 93.32 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 68 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 34.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 38 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 92.58 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 72.81 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 42 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 85.51 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 49 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 97.04 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 51 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 14.78 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 6698 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 259.50 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 30.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 101 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 79.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 86 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 329.26 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 88.08 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 85 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 101.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 87 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 76.79 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 65 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 72.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 85 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 338.17 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 22 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 85.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 90.20 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 56.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 85.49 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 61 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 33.09 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 52 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 295.38 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 78.30 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 9 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 74.72 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 102 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 127.53 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 25 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 327.12 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 212.61 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 171.57 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 38 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 69.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 62 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 19.74 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 249 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 308.25 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 94.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 68 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 37.52 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 62 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 105.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 74 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 391.94 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 25 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 77.27 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 78 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 104.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 76 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 67.90 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 100 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 32.52 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 53 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 73.16 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 88 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 68.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 73 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 58.44 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 96 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 70.39 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 46 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 251.33 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 324.40 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 31 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 94.79 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 58 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab | Cycle 17 Day 1- Pre-dose | 101.27 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 66 |
Secondary
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Time frame: Cycle 1 Day 1 (pre-dose and post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Population: Analysis was performed on PK analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations and 0 in the number analyzed signifies no participant with available data at specified time-points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 105.78 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 36.32 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 43 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 48.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 25 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 2.13 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 68.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 46.36 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 48.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 38.56 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 40 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 40.32 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 54 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 16.16 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 33 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 48.39 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 70.24 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 37.29 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 128 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 52.34 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 26 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 35.45 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 98 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 107.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 37.47 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 95 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 47.22 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 42 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 17.22 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 45.40 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 105.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 44.47 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 35.20 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 70.07 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 31.50 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 65 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 46.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 16.51 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 34.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 47 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 43.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 40.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 51.62 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 17.00 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 39.78 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 36 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 48.96 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 55 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 47.24 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 104.12 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 1.35 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 38.54 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 65.59 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 49.65 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 40 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 42.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 25.78 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 100.39 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 36.32 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 46 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 39.30 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 47 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 29.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 59 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 45.87 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 59 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 86.72 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 51.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 11 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 42.50 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 53 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 38.19 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 36.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 93 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 65.15 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 22 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 39.78 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 22 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 14.31 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 21.40 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 40.62 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | 36.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 97.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 36.71 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 10 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 12.58 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 36 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 44.63 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 47 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 72.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 26 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 63.54 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 77 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 52.88 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 11 |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 28.96 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 50 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 37.33 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 67 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 47.08 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 70 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 48.29 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 51 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 17.33 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 41 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 109.71 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 48.23 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 68 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 43.60 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 69.50 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 2 Day 1-Pre-dose | 13.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 38 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 1 Day 1-Post-dose | 59.14 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 6 Day 1-Pre-dose | 29.37 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 64 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 25 Day 1-Pre-dose | 16.83 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 117 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 13 Day 1-Pre-dose | 36.61 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 75 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Pre-dose | 29.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 9 Day 1-Pre-dose | 27.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 138 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 17 Day 1-Pre-dose | 40.14 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 86 |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab | Cycle 5 Day 1-Post-dose | 86.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
Secondary
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Time frame: Up to 30 days after the last dose of study interventions (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Population: Analysis was performed on safety set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 21 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 41 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 30 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 28 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 33 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 43 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 15 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 17 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 44 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 23 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 43 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 31 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 25 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 12 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 9 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 11 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 21 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 16 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 6 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 6 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 4 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 27 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 22 Participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 41 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 49 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 60 Participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 32 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 10 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 23 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 9 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 18 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 8 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 10 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Serious TEAE | 13 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with any TEAE | 23 Participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs | Participants with >= Grade 3 TEAE | 15 Participants |
Secondary
Phase 1b: DCR as Per RECIST v.1.1
DCR was defined as the percentage of participants with BOR, as per RECIST v.1.1, of a CR, PR, or SD. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Population: Analysis was performed on efficacy evaluable analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b: DCR as Per RECIST v.1.1 | 90.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b: DCR as Per RECIST v.1.1 | 92.9 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b: DCR as Per RECIST v.1.1 | 86.7 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b: DCR as Per RECIST v.1.1 | 90.2 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b: DCR as Per RECIST v.1.1 | 53.8 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b: DCR as Per RECIST v.1.1 | 94.7 percentage of participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: DCR as Per RECIST v.1.1 | 83.3 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b: DCR as Per RECIST v.1.1 | 69.2 percentage of participants |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b: DCR as Per RECIST v.1.1 | 86.4 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b: DCR as Per RECIST v.1.1 | 34.8 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: DCR as Per RECIST v.1.1 | 26.3 percentage of participants |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b: DCR as Per RECIST v.1.1 | 34.8 percentage of participants |
Secondary
Phase 1b: DOR as Per RECIST v.1.1
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Population: Analysis was performed on participants in efficacy evaluable analysis set with an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b: DOR as Per RECIST v.1.1 | 16.9 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b: DOR as Per RECIST v.1.1 | 13.9 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b: DOR as Per RECIST v.1.1 | 14.0 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b: DOR as Per RECIST v.1.1 | 4.1 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b: DOR as Per RECIST v.1.1 | 15.9 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b: DOR as Per RECIST v.1.1 | 8.0 months |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: DOR as Per RECIST v.1.1 | 3.4 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b: DOR as Per RECIST v.1.1 | 8.5 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b: DOR as Per RECIST v.1.1 | 8.4 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b: DOR as Per RECIST v.1.1 | 16.6 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: DOR as Per RECIST v.1.1 | NA months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b: DOR as Per RECIST v.1.1 | 8.3 months |
Secondary
Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1
PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Time frame: From first dose of study drugs to the date of the first documentation of PD or death, whichever came first (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 8.2 months |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 11.3 months |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 5.5 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 4.9 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 2.9 months |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 7.9 months |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 4.9 months |
| Phase 1b: Dose Expansion: Cohort 8 | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 5.7 months |
| Phase 1b: Dose Expansion: Cohort 9 | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 7.3 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 2.8 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 1.9 months |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1 | 8.2 months |
Secondary
Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1
DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Population: Analysis was performed on efficacy evaluable analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 33.3 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 50 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 50 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 40 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 33.3 percentage of participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1 | 50 percentage of participants |
Secondary
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were measured. Post-dose refers to the data collected for 30 minutes post-infusion. C in the timeframe below refers to Cycle and D refers to Day and h refers to hours.
Time frame: C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)
Population: Analysis was performed on the pharmacokinetic (PK) analysis set that included all participants who received \>= 1 dose of any component of study drugs per the protocol, and for whom any corresponding post-dose PK data were available. Here, number analyzed' = participants with available data of serum concentrations and 0 in the number analyzed signifies no participants with available data at specified time-points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 13.90 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 1.34 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 post-dose | 14.70 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 2.58 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 10.30 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 6.49 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 0.33 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 18.43 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- post-dose | 40.40 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- post-dose | 35.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 9.05 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 15.30 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 6.94 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 8.38 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 31.67 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 11.49 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 8.12 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 7.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 2.23 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 42 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 post-dose | 44.59 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 7.57 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 48.11 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 39 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 5.44 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 55.27 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 8 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 145.89 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 30 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 29.30 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 46 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 77.59 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 14 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 36.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 23.92 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 102 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 post-dose | 130.22 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 8.71 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 109 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- post-dose | 150.44 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 64.36 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 17 Day1- Pre-dose | 45.50 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 44.80 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 98.28 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 16 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- post-dose | 156.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 3 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 41.16 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 43 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 25 Day 1- Pre-dose | 47.20 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 28.39 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 136.15 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 12 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 post-dose | 259.66 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 198.72 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 14 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 90.08 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 64.72 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 24.96 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 71 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 277.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 46.15 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 108 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- post-dose | 298.93 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 140.04 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 96.09 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 54 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 66.59 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 64 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- post-dose | 343.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 23 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 49.92 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 41 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 66.70 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 154.07 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 11 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 121.94 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 460.48 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 45 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 17 Day1- Pre-dose | 113.00 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 0 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- post-dose | 726.95 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 8 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 23.85 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 87 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 101.42 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 40 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1 post-dose | 525.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 140.64 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 10 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 150.95 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 31 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 256.28 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 35 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 80.56 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 111 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 179.05 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 36 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 265.52 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 26 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- post-dose | 589.07 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 19 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 374.44 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
Secondary
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Serum Concentrations of Tislelizumab was determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Time frame: Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)
Population: Analysis was performed on PK analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations and 0 in the number analyzed signifies no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 2 Day 1 Predose | 11.50 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Post-dose | 54.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Predose | 0.45 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Postdose | 63.40 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Predose | 16.50 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Post-dose | 62.89 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 38 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 2 Day 1 Predose | 14.17 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 69 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Predose | 17.50 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 6 Day 1 Predose | 27.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 9 Day 1 Predose | 29.10 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 13 Day 1 Predose | 27.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 25 Day 1 Predose | 31.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 25 Day 1 Predose | 56.20 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 17 Day 1 Predose | 43.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 6 Day 1 Predose | 24.08 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 38 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Predose | 30.79 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 32 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 9 Day 1 Predose | 36.28 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 2 Day 1 Predose | 20.05 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 93 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 13 Day 1 Predose | 36.70 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Predose | 14.46 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 350 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Postdose | 102.03 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 5 |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Post-dose | 82.34 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 48 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 13 Day 1 Predose | 33.60 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 2 Day 1 Predose | 18.61 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 82 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Predose | 21.91 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 109 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Postdose | 76.71 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 6 Day 1 Predose | 29.22 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 74 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 9 Day 1 Predose | 30.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Post-dose | 67.93 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 46 |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Predose | 18.60 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 528 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 9 Day 1 Predose | 37.67 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 6 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Postdose | 98.97 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Predose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 5 Day 1 Predose | 33.64 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 13 Day 1 Predose | 25.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 39 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 2 Day 1 Predose | 10.37 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 72 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 17 Day 1 Predose | 26.79 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 4 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 6 Day 1 Predose | 40.73 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 18 |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab | Cycle 1 Day 8 Post-dose | 60.28 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
Secondary
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Serum concentration of ociperlimab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. C in the timeframe below refers to Cycle and D refers to Day and h refers to hours.
Time frame: Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days)
Population: Analysis was performed on PK Analysis set. Here, number analyzed' = participants with available data for the analysis of serum concentrations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Predose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 313.57 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 21 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 230.81 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 29 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 138.16 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 43 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 102.68 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 67.27 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 52 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 42.52 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 58 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 336.36 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 24 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 105.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 458.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 217.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 200.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 132.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Post-dose | 552.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 131.00 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 96.50 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 13 Day 1- Pre-dose | 61.30 micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Predose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Pre-dose | 43.02 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- Post-dose | 267.78 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 27 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Pre-dose | 53.96 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 11 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 24 h | 201.98 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- Post-dose | 360.55 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 18 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 72 h | 141.37 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 15 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 9 Day 1- Pre-dose | 66.92 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 14 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 168 h | 99.84 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 20 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 168 h | 126.19 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 6 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 1 Day 1- 336 h | 59.10 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 28 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 6 Day 1- Post-dose | 355.69 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Pre-dose | 30.53 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 58 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 5 Day 1- 336 h | 76.09 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab | Cycle 2 Day 1- Post-dose | 316.63 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 13 |
Secondary
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Time frame: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days)
Population: Analysis was performed on PK Analysis set. Here number analyzed = participants with available data for analysis of serum concentrations. Data was not collected and analyzed for the Phase 1: Dose Verification: Cohort 1A arm because tislelizumab was not administered in that arm.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 1 Day 1- Pre-dose | NA micrograms per milliliter (mcg/mL) | — |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 1 Day 1 Post-dose | 62.35 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 26 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 2 Day 1- Pre-dose | 14.67 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 34 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 5 Day 1- Pre-dose | 33.34 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 22 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 5 Day 1- Post-dose | 117.68 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 9 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 6 Day 1- Pre-dose | 36.41 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 4 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 9 Day 1- Pre-dose | 46.76 micrograms per milliliter (mcg/mL) | Geometric Coefficient of Variation 6 |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab | Cycle 13 Day 1- Pre-dose | 48.30 micrograms per milliliter (mcg/mL) | — |
Secondary
Phase 1: Duration of Response (DOR) as Per RECIST v.1.1
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Population: Analysis was performed on participants in the efficacy evaluable analysis set with an objective response. Here, 0 in the overall number of participants analyzed signifies no participants with available data at the specified time-points.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 | 2.8 months |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 | 3.6 months |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 | 8.4 months |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Duration of Response (DOR) as Per RECIST v.1.1 | 7 months |
Secondary
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Time frame: Up to 32.2 months (Dose escalation cohorts) and up to 11 months (Dose verification cohorts)
Population: Analysis was performed on ADA Analysis Set that included all participants who received at least 1 dose of any component of study drugs for whom both baseline antidrug antibody result and at least 1 corresponding post-baseline antidrug antibody result are available. Here, number analyzed = participants with available data for the ADA analysis and 0 in the number analyzed signifies no participant were available for analysis at specified time-points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 2 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 1 Participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Induced ADAs | 1 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Boosted ADAs | 1 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: Treatment-Emergent ADAs | 2 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: NAb Positive | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Boosted ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Induced ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Ociperlimab: Treatment-Emergent ADAs | 0 Participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab | Tislelizumab: NAb Positive | 0 Participants |
Secondary
Phase 1: ORR as Per RECIST v.1.1
ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)
Population: Analysis was performed on efficacy evaluable analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Phase 1: ORR as Per RECIST v.1.1 | 0.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Phase 1: ORR as Per RECIST v.1.1 | 0.0 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Phase 1: ORR as Per RECIST v.1.1 | 16.7 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Phase 1: ORR as Per RECIST v.1.1 | 6.3 percentage of participants |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Phase 1: ORR as Per RECIST v.1.1 | 20 percentage of participants |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Phase 1: ORR as Per RECIST v.1.1 | 0.0 percentage of participants |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Phase 1: ORR as Per RECIST v.1.1 | 10 percentage of participants |