Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
NCT04047862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 446
Last updated 2025-08-22
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.
Conditions
- Locally Advanced and Metastatic Solid Tumors
Interventions
- DRUG
-
Ociperlimab
Administered as an intravenous (IV) injection
- DRUG
-
Tislelizumab
Administered as an IV injection
- DRUG
-
Pemetrexed
Administered in accordance with local guidelines, prescribing information/summary of product
- DRUG
-
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Nab paclitaxel
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Etoposide
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
5fluorouracil
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Administered in accordance with local guidelines , prescribing information/summary of product
- DRUG
-
Administered in accordance with local guidelines , prescribing information/summary of product
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
Study Director · BeiGene
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-15
- Primary Completion
- 2024-08-07
- Completion
- 2024-08-07
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- New Zealand
- South Korea
- Taiwan
Study Locations
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