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QLS5132 Combination Therapy in Advanced Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
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.
Official title: A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
626
Start Date
2026-04
Completion Date
2029-02
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
QLS5132; Bevacizumab
Intravenous infusion,Q3W
QLS5132; Platinum; Bevacizumab
Intravenous infusion,Q3W
QLS5132; Olaparib; Bevacizumab
Olaparib is oral; all others are intravenous infusion,Q3W
QLS5132; QL1706; QL2107
Intravenous infusion,Q3W
QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin
Intravenous infusion,Q3W