NCT07151872

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• CLDN18.2-positive Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-09-03
• Last updated: 2025-09-03