MedTrace Logo

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

NCT07151872 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-10-31
Completion
2026-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07151872 on ClinicalTrials.gov