A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Active, not recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

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

Details

• Lead Sponsor: BeiGene
• Treatments: Tislelizumab

Criteria

Inclusion Criteria:

• Able to provide written informed consent and can agree to comply with the study requirements.

• Participants with metastatic ESCC or unresectable, locally advanced ESCC.

• Histologically confirmed diagnosis of ESCC.

• Can provide a tumor sample.

• At least 1 measurable lesion as defined by RECIST v1.1.

• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Exclusion Criteria:

• Prior treatment for advanced or metastatic ESCC within the past 6 months

• Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator

• Palliative radiation treatment for ESCC within the past 4 weeks

• Participants with an esophageal/bronchial or esophageal/aorta fistula

• Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs

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