Clinical Trial

QLS5132 Combination Therapy in Advanced Solid Tumors

Not Yet Recruiting Phase 1/2
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Summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and effectiveness of the investigational drug QLS5132 (injectable) in combination with other therapies for participants with advanced solid tumors. This is a multicenter, open-label study consisting of two parts: dose escalation and tumor-specific expansion. The main questions it aims to answer are: * In the dose-escalation part: What is the safety, tolerability, PK profile, and preliminary efficacy of QLS5132 combination therapy, and what are the recommended dose(s) for expansion? * In the expansion part: What is the anti-tumor efficacy and further safety profile of QLS5132 combination therapy at the selected dose(s) in participants with specific tumor types? Participants will: * Be enrolled in sequential cohorts to receive QLS5132 in combination with other anticancer agents. * Undergo regular assessments for safety, drug concentration levels (PK), and tumor response.
Trial Details
NCT Number NCT07453394
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Gastric Cancer (GC), Non-small Cell Lung Cancer (NSCLC), Endometrial Cancer, Advanced Solid Tumors, Ovarian Cancer
Enrollment 626 participants
Start Date 2026-04
Primary Completion 2027-04 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-06