Linear Clinical Research | Perth, Australia
Status and phase
Conditions
Treatments
About
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Phase 1 Key Inclusion Criteria
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 is 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
Willing to use highly effective method of birth control
Phase 1 Key Exclusion Criteria:
Phase 1b Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
449 participants in 11 patient groups
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Central trial contact
BeiGene
Data sourced from clinicaltrials.gov
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