At a glance
ClinicalIndex Comparison Record- ✓Phase 1: Advanced, metastatic, unresectable solid tumors with prior standard therapy or treatment not available/tolerated/refused
- ✓Phase 1b: Histologically/cytologically confirmed tumor in one of 10 disease cohorts (NSCLC stages, SCLC, ESCC, EAC, HNSCC, gastric cancer)
- ✓Age >= 18 years at time of informed consent (Phase 1b)
- ✓At least one measurable lesion per RECIST v1.1 (Phase 1)
- ✕Phase 1: Prior therapies targeting TIGIT
- ✕Phase 1b: Any prior therapy for recurrent/metastatic disease
- ✕Phase 1b: Prior checkpoint inhibitor therapy (exception: anti-PD(L)1 allowed for Cohort 5)
- ✕Phase 1b: Non-squamous NSCLC with sensitizing EGFR mutation, ALK fusion, or ROS1 fusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Ociperlimab, Tislelizumab, and 9 other interventions for Locally Advanced and Metastatic Solid Tumors. Completed, enrolled 446 participants across 65 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered as an intravenous (IV) injection
Administered as an IV injection
Administered in accordance with local guidelines, prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product
Administered in accordance with local guidelines , prescribing information/summary of product