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NOT YET RECRUITING
NCT07151872
PHASE2

Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09

Completion Date

2026-10

Last Updated

2025-09-03

Healthy Volunteers

No

Interventions

DRUG

QLS31905 for Injection

QLS31905 for Injection

DRUG

Gemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for Injection

DRUG

Cisplatin for Injection

Cisplatin for Injection

DRUG

QL2107 Injection

QL2107 Injection

DRUG

Oxaliplatin Injection

Oxaliplatin Injection

DRUG

Capecitabine Tablets

Capecitabine Tablets