QLS5132 Combination Therapy in Advanced Solid Tumors

March 4, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

626

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QLS5132 combined wtih bevacizumab
QLS5132 in combination with bevacizumab
Drug: QLS5132; Bevacizumab
Intravenous infusion，Q3W
Experimental: QLS5132 combined wtih platinum
QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab
Drug: QLS5132; Platinum; Bevacizumab
Intravenous infusion，Q3W
Experimental: QLS5132 combined wtih Olaparib
QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab
Drug: QLS5132; Olaparib; Bevacizumab
Olaparib is oral; all others are intravenous infusion，Q3W
Experimental: QLS5132 combined wtih immune checkpoint inhibitors
QLS5132 in combination with immune checkpoint inhibitors
Drug: QLS5132; QL1706; QL2107
Intravenous infusion，Q3W
Experimental: QLS5132 combined with immune checkpoint inhibitors and chemotherapy
QLS5132 in combination with immune checkpoint inhibitors and chemotherapy
Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin
Intravenous infusion，Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: up to 2 years
Incidence and severity of adverse events
up to 2 years
Maximum tolerated dose (MTD)
Time Frame: From basline to Day 28
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
From basline to Day 28
Recommended Phase 2 Dose (RP2D)
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLS5132-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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