Clinical Trial

Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

Not Yet Recruiting Phase 1
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Summary
The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion): * Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels. * Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1\~3 selected dose levels follow successful Phase 1a results.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-10.
Trial Details
NCT Number NCT06932094
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Advanced Solid Tumors
Enrollment 256 participants
Start Date 2025-05
Primary Completion 2027-05 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2025-04-23