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

BeiGene

Status and phase: Active, not recruiting; Phase 2

Conditions: Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma by AJCC V8 Stage

Treatments: Drug: LBL-007; Drug: Chemotherapy Doublet; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06010303

CTR20233227 (Registry Identifier)

BGB-A317-LBL-007-202

Details and patient eligibility

About

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).

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

LBL-007

Experimental group

Description:

LBL-007 in combination with tislelizumab plus chemotherapy doublet.

Treatment:

Drug: Tislelizumab

Drug: Chemotherapy Doublet

Drug: LBL-007

Tislelizumab and Chemotherapy

Active Comparator group

Description:

Tislelizumab plus chemotherapy doublet.

Treatment:

Drug: Tislelizumab

Drug: Chemotherapy Doublet