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NOT YET RECRUITING
NCT07453394
PHASE1/PHASE2

QLS5132 Combination Therapy in Advanced Solid Tumors

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

QLS5132; Bevacizumab

Intravenous infusion,Q3W

DRUG

QLS5132; Platinum; Bevacizumab

Intravenous infusion,Q3W

DRUG

QLS5132; Olaparib; Bevacizumab

Olaparib is oral; all others are intravenous infusion,Q3W

DRUG

QLS5132; QL1706; QL2107

Intravenous infusion,Q3W

DRUG

QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin

Intravenous infusion,Q3W