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
1 other identifier
interventional
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2025
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedFirst Posted
Study publicly available on registry
September 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
September 3, 2025
August 1, 2025
1.1 years
August 25, 2025
August 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ORR (Objective Response Rate)
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
Approximately 24 months
Study Arms (3)
QLS31905 +GP
EXPERIMENTALQLS31905 +GP+QL2107
EXPERIMENTALQLS31905 +XELOX
EXPERIMENTALInterventions
Gemcitabine Hydrochloride for Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 3, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
September 3, 2025
Record last verified: 2025-08