Status:
NOT_YET_RECRUITING
Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
CLDN18.2-positive Advanced Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 Pat...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07151872
Start Date
September 1 2025
End Date
October 1 2026
Last Update
September 3 2025
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