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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07151872

Enrollment

120

Registered

2025-09-03

Start date

2025-09-30

Completion date

2026-10-31

Last updated

2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLDN18.2-positive Advanced Biliary Tract Cancer

Brief 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

Interventions

DRUGQLS31905 for Injection

QLS31905 for Injection

DRUGGemcitabine Hydrochloride for Injection

Gemcitabine Hydrochloride for Injection

DRUGCisplatin for Injection

Cisplatin for Injection

DRUGQL2107 Injection

QL2107 Injection

DRUGOxaliplatin Injection

Oxaliplatin Injection

DRUGCapecitabine Tablets

Capecitabine Tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
ORR (Objective Response Rate)	Approximately 24 months	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1

Contacts

Primary ContactTongsen Zheng, PHD

zhengtongsen@126.com15134569619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026