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

Phase 1 Completed 446 enrolled BeiGene

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-08-15
Primary completion: 2024-08-07
Completion: 2024-08-07

Publications

Results Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. J Immunother Cancer. 2023 Oct;11(10):e005829. doi: 10.1136/jitc-2022-005829.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ociperlimab	Monoclonal antibody	50 mg	Intravenous
Subject	Ociperlimab	Monoclonal antibody	150 mg	Intravenous
Subject	Ociperlimab	Monoclonal antibody	450 mg	Intravenous
Subject	Ociperlimab	Monoclonal antibody	900 mg	Intravenous
Subject	Ociperlimab	Monoclonal antibody	1800 mg	Intravenous
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Background	Capecitabine	Small molecule	1000 mg/m2	—
Background	Carboplatin	Small molecule	5 unknown	—
Background	Carboplatin	Small molecule	6 unknown	—
Background	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Etoposide	Small molecule	100 mg/m2	—
Background	Oxaliplatin	Small molecule	1300 mg/m2	—
Background	Paclitaxel	Small molecule	100 mg/m2	—
Background	Paclitaxel	Small molecule	175 mg/m2	—
Background	Paclitaxel	Small molecule	200 mg/m2	—
Background	Pemetrexed	Small molecule	500 mg/m2	—
Background	fluorouracil	Small molecule	750 mg/m2	—
Background	fluorouracil	Small molecule	800 mg/m2	—

Indications

No indication recorded.