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QLS5132 Combination Therapy in Advanced Solid Tumors

NCT07453394 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

QLS5132; Bevacizumab

Intravenous infusion，Q3W

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2029-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453394 on ClinicalTrials.gov