Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Locally Advanced and Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT04047862
- Lead Sponsor
- BeiGene
- Brief Summary
The primary objectives of this study are : 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 is to assess overall response rate (ORR) determined by Investigator per RECIST v1.1 for patients in each dose- expansion cohort
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 449
Inclusion Criteria
Phase 1 Key Inclusion Criteria
- Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
- ≥ 1 measurable lesion per RECIST v1.1.
- Has adequate organ function.
- phase 1- Patients with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
Phase 1b Key Inclusion Criteria
-
Signed informed consent form (ICF) and able to comply with study requirements.
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Age ≥ 18 years (or the legal age of consent) at the time the ICF is signed.
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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.
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ECOG Performance Status ≤ 1
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Adequate organ function
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Willing to use highly effective method of birth control
Phase 1 Key
Exclusion Criteria
- Active brain or leptomeningeal metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With 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).
- Concurrent participation in another therapeutic clinical trial.
- Received prior therapies targeting TIGIT.
Phase 1b Key Exclusion Criteria:
- Patients with any prior therapy for recurrent/metastatic disease.
- Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
- Gastric cancer patients with squamous or with positive HER2 expression.
- Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With 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).
- Concurrent participation in another therapeutic clinical study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 1 Tislelizumab Cycle 1 (28 Days): A flat dose of ociperlimab as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8. If ociperlamib is tolerated in Cycle 1, participants will receive tislelizumab + ociperlimab sequentially on Day 29 and every 21 days for up to 8 months. Phase 1b Cohort 1 Tislelizumab Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W) Phase 1b Cohort 1 Paclitaxel Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W) Phase 1b Cohort 2 Ociperlimab Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W) Phase 1b Cohort 1 Nab paclitaxel Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W) Phase 1b Cohort 1 Carboplatin Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W) Phase 1b Cohort 2 Tislelizumab Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W) Phase 1b Cohort 2 Pemetrexed Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W) Phase 1b Cohort 2 Carboplatin Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W) Phase 1b Cohort 2 Cisplatin Participants with metastatic squamous NSCLC will receive ociperlimab + tislelizumab + pemetrexed + Cis/Carbo Q3W for 4 to 6 cycles (21 days each) followed by ociperlamib+tislelizumab Q3W) Phase 1b Cohort 3 Tislelizumab Participants with metastatic NSCLC (PD-L1 positive, \[TC\] ≥ 1%) will be treated with ociperlimab + tislelizumab Phase 1b Cohort 4 Ociperlimab Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W Phase 1b Cohort 4 Tislelizumab Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W Phase 1b Cohort 4 Carboplatin Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W Phase 1b Cohort 4 Cisplatin Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 8 Tislelizumab Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with ociperlimab + tislelizumab Q3W Phase 1b Cohort 4 Etoposide Patients with extensive stage SCLC will be treated with ociperlimab + tislelizumab + etoposide + Cis/Carbo Q3W for up to 6 to 8 cycles followed by ociperlamib+tislelizumab Q3W Phase 1b Cohort 5 Tislelizumab Checkpoint inhibitor (CPI)-experienced NSCLC patients will be treated with ociperlimab plus tislelizumab Phase1b Cohort 6 Tislelizumab Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 6 Paclitaxel Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 6 Cisplatin Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 7 5fluorouracil Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 6 5fluorouracil Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 7 Tislelizumab Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 7 Paclitaxel Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 7 Cisplatin Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 9 Ociperlimab Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase1b Cohort 9 Cisplatin Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase1b Cohort 9 5fluorouracil Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase 1b Cohort10 Tislelizumab Patients with metastatic NSCLC (PD-L1 positive, \[TC\] ≥ 1%) will be treated with tislelizumab in combination with ociperlimab 450mg, 900mg or 1800mg Q3W. Phase1b Cohort 9 Tislelizumab Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase1b Cohort 9 Oxaliplatin Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase1b Cohort 9 Capecitabine Patients with metastatic G/GEJ carcinoma will be treated with ociperlimab + tislelizumab + \[oxalipatin + capecitabine\] or \[cisplatin + 5-fluorouracil\] Q3W for 6 cycles followed by ociperlamib+tislelizumab + capecitabine Q3W Phase 1b Cohort 1 Ociperlimab Participants with metastatic squamous NSCLC will receive ociperlamib + tislelizumab + paclitaxel/nab-paclitaxel + Carbo once every 3 weeks (Q3W) for 4 to 6 cycles (21 days each) followed by ociperlimab + tislelizumab Q3W) Phase 1 Ociperlimab Cycle 1 (28 Days): A flat dose of ociperlimab as a single agent on Day 1. In the first cycle, 200 mg tislelizumab will be administered on Day 8. If ociperlamib is tolerated in Cycle 1, participants will receive tislelizumab + ociperlimab sequentially on Day 29 and every 21 days for up to 8 months. Phase1b Cohort 7 Ociperlimab Patients with metastatic EAC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil or paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase 1b Cohort 5 Ociperlimab Checkpoint inhibitor (CPI)-experienced NSCLC patients will be treated with ociperlimab plus tislelizumab Phase 1b Cohort10 Ociperlimab Patients with metastatic NSCLC (PD-L1 positive, \[TC\] ≥ 1%) will be treated with tislelizumab in combination with ociperlimab 450mg, 900mg or 1800mg Q3W. Phase 1b Cohort 3 Ociperlimab Participants with metastatic NSCLC (PD-L1 positive, \[TC\] ≥ 1%) will be treated with ociperlimab + tislelizumab Phase1b Cohort 6 Ociperlimab Patients with metastatic ESCC will be treated with ociperlimab + tislelizumab + cisplatin + 5-fluorouracil /paclitaxel Q3W for 6 cycles followed by ociperlamib+tislelizumab Q3W Phase1b Cohort 8 Ociperlimab Patients with recurrent or metastatic HNSCC (PD-L1 positive, vCPS≥ 1%) will be treated with ociperlimab + tislelizumab Q3W
- Primary Outcome Measures
Name Time Method Phase 1 Dose Escalation - Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0) Up to 28 Days in Cycle 1 Phase 1 Dose Escalation - Number of participants experiencing Serious Adverse Events (SAEs) Up to 1.5 years Phase 1 Dose Escalation - Recommended Phase Ib dose (RP2D) of ociperlimab in combination with tislelizumab Up to 1.5 years Phase 1b Dose Confirmation - Anti-tumor activity of ociperlimab in combination with tislelizumab in patients with select advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using RECIST v. 1.1. Up to 1.5 years
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Up to 3 years Duration of response (DOR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Disease control rate (DCR) Up to 3 years Disease control rate (DCR) will be determined from investigator derived tumor assessments per RECIST v. 1.1.
Progression free survival Up to 3 years Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1.
Immunogenicity as assessed by the presence of anti-drug antibodies Up to 3 years
Trial Locations
- Locations (65)
Mayo Clinic Phoenix
🇺🇸Phoenix, Arizona, United States
Scri Florida Cancer Specialists South
🇺🇸Fort Myers, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Scri Florida Cancer Specialists North
🇺🇸Saint Petersburg, Florida, United States
University of Kansas Medical Center Research Institute
🇺🇸Kansas City, Kansas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Tennessee Oncology, Pllc Nashville
🇺🇸Nashville, Tennessee, United States
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