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Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors

NCT03744468 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2026-04-02

Study results available
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Summary

This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.

Conditions

  • Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in
  • HNSCC for Phase 2 Dose Expansion
  • NSCLC for Phase 2 Dose Expansion

Interventions

DRUG

Surzebiclimab

Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3

DRUG

Tislelizumab

Humanized, IgG4-variant monoclonal antibody against PD-1

DRUG

Alcestobart

Human anti LAG-3 antibody

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
2018-11-13
Primary Completion
2025-02-06
Completion
2025-02-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Italy
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744468 on ClinicalTrials.gov