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Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
Sponsor: Qilu Pharmaceutical Co., Ltd.
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
QLS31905 for Injection
QLS31905 for Injection
Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for Injection
Cisplatin for Injection
Cisplatin for Injection
QL2107 Injection
QL2107 Injection
Oxaliplatin Injection
Oxaliplatin Injection
Capecitabine Tablets
Capecitabine Tablets