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Clinical Trials associated with QLS5132 / Not yet recruitingPhase 1/2 A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors
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.
/ Not yet recruitingPhase 1 A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors
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.
100 Clinical Results associated with QLS5132
100 Translational Medicine associated with QLS5132
100 Patents (Medical) associated with QLS5132
100 Deals associated with QLS5132