drugset / Trial / NCT07453394

QLS5132 Combination Therapy in Advanced Solid Tumors

NCT07453394

Phase 1/2 Not yet recruiting 626 enrolled Qilu Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-04
Primary completion
2027-04
Completion
2029-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody Intravenous
Subject Carboplatin Small molecule Intravenous
Subject Cisplatin Other / unclassified Intravenous
Subject Olaparib Small molecule Oral
Subject Oxaliplatin Small molecule Intravenous
Subject QL1706 Monoclonal antibody Intravenous
Subject QL2107 Unknown Intravenous
Subject QLS5132 Other / unclassified