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QLS5132 Combination Therapy in Advanced Solid Tumors | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

QLS5132 Combination Therapy in Advanced Solid Tumors

A Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenous QLS5132 Combination Therapy in Participants With Advanced Solid Tumors

NCT07453394•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Advanced solid tumors;
•2. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•4. Adequate organ function;
•5. Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral.

Exclusion Criteria

•1. Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates \[ADCs\]), or any drug containing topoisomerase I inhibitors (including ADCs);
•2. Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 2 weeks with small molecule and within 4 weeks with biologic before the first dose of QLS5132;
•3. Progressive or symptomatic brain metastases;
•4. Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
•5. History of significant cardiac disease, or poorly controlled diabetes mellitus;
•6. History of recurrent autoimmune diseases;
•7. History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
•8. History of a second primary malignancy;
•9. If female, is pregnant or breastfeeding;
•10. Be allergic to any component of QLS5132 or its excipients.

Key Dates

Start Date

April 1, 2026

Primary Completion Date

April 1, 2027

Completion Date

February 1, 2029

Last Updated

March 6, 2026

Enrollment

626

ESTIMATED participants

Conditions

Gastric Cancer (GC)Non-small Cell Lung Cancer (NSCLC)Endometrial CancerAdvanced Solid TumorsOvarian Cancer

Interventions

QLS5132; Bevacizumab

DRUG

QLS5132; Platinum; Bevacizumab

DRUG

QLS5132; Olaparib; Bevacizumab

DRUG

QLS5132; QL1706; QL2107

DRUG

QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin

DRUG

Contacts

Tao Zhu, PhD

CONTACT

+86 13858065156 zhutao@zjcc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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QLS5132 Combination Therapy in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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