Status:
COMPLETED
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
Lead Sponsor:
BeiGene
Conditions:
Locally Advanced and Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Phas...
Eligibility Criteria
Inclusion
- Key
- Phase 1 Key Inclusion Criteria
- Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1.
- Greater than or equal to (\>=) measurable lesion per RECIST v1.1.
- Had adequate organ function.
- 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
- Signed informed consent form (ICF) and able to comply with study requirements.
- Age \>= 18 years (or the legal age of consent) at the time the ICF was signed.
- 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.
- ECOG Performance Status \<= 1
- Adequate organ function
- Were willing to use highly effective method of birth control
- Phase 1 Key
Exclusion
- Active brain or leptomeningeal metastasis.
- Active autoimmune diseases or history of autoimmune diseases that could have relapsed.
- 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).
- Concurrent participation in another therapeutic clinical trial.
- Received prior therapies targeting TIGIT.
- Phase 1b Key
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2024
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT04047862
Start Date
August 15 2019
End Date
August 7 2024
Last Update
August 22 2025
Active Locations (65)
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1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85254
2
Scri Florida Cancer Specialists South
Fort Myers, Florida, United States, 33901
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
Scri Florida Cancer Specialists North
St. Petersburg, Florida, United States, 33705