NCT04047862

Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors

Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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	Paclitaxel	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	Carboplatin	Administered in accordance with local guidelines , prescribing information/summary of product
DRUG	Cisplatin	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	Oxaliplatin	Administered in accordance with local guidelines , prescribing information/summary of product
DRUG	Capecitabine	Administered in accordance with local guidelines , prescribing information/summary of product

Timeline

• Start date: 2019-08-15
• Primary completion: 2024-08-07
• Completion: 2024-08-07
• First posted: 2019-08-07
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

65 sites across 6 countries: United States, Australia, China, New Zealand, South Korea, Taiwan

Regulatory

• FDA-regulated drug study