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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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CLDN18.2-positive Advanced Biliary Tract Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLS31905 +GP

Group Type EXPERIMENTAL

QLS31905 for Injection

Intervention Type DRUG

QLS31905 for Injection

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Cisplatin for Injection

Intervention Type DRUG

Cisplatin for Injection

QLS31905 +GP+QL2107

Group Type EXPERIMENTAL

QLS31905 for Injection

Intervention Type DRUG

QLS31905 for Injection

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Cisplatin for Injection

Intervention Type DRUG

Cisplatin for Injection

QL2107 Injection

Intervention Type DRUG

QL2107 Injection

QLS31905 +XELOX

Group Type EXPERIMENTAL

QLS31905 for Injection

Intervention Type DRUG

QLS31905 for Injection

Oxaliplatin Injection

Intervention Type DRUG

Oxaliplatin Injection

Capecitabine Tablets

Intervention Type DRUG

Capecitabine Tablets

Interventions

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QLS31905 for Injection

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Cisplatin for Injection

Intervention Type DRUG

QL2107 Injection

Intervention Type DRUG

Oxaliplatin Injection

Intervention Type DRUG

Capecitabine Tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination;
* Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
* No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer.

Exclusion Criteria

* Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
* Subjects had other second primary malignancies within 5 years prior to the first dose;
* Subjects with clinically significant hemorrhage within 3 months before the first dose;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No