AdvanTIG-203: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) visually estimated combined positive score (vCPS) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.

2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.

3. Have measurable disease as assessed by RECIST v1.1.

4. Have confirmed PD-L1 vCPS ≥ 10% in tumor tissues tested by the central lab.

5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

Key Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).

3. Evidence of complete esophageal obstruction not amenable to treatment.

4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).

5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.