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NCT Number: NCT07453394

QLS5132 Combination Therapy in 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.

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Key information

Conditions

Gastric Cancer (GC) Adnexal Diseases Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer (NSCLC) Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced solid tumors;
  • Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Adequate organ function;
  • 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

  • Previous treatment with drugs targeting CLDN6 (including antibody-drug conjugates [ADCs]), or any drug containing topoisomerase I inhibitors (including ADCs);
  • 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;
  • Progressive or symptomatic brain metastases;
  • Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection;
  • History of significant cardiac disease, or poorly controlled diabetes mellitus;
  • History of recurrent autoimmune diseases;
  • History of myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML);
  • History of a second primary malignancy;
  • If female, is pregnant or breastfeeding;
  • Be allergic to any component of QLS5132 or its excipients.

Treatment and study plan

QLS5132; Bevacizumab

Drug

Intravenous infusion，Q3W

QLS5132; Platinum; Bevacizumab

Drug

Intravenous infusion，Q3W

QLS5132; Olaparib; Bevacizumab

Drug

Olaparib is oral; all others are intravenous infusion，Q3W

QLS5132; QL1706; QL2107

Drug

Intravenous infusion，Q3W

QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin

Drug

Intravenous infusion，Q3W

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: up to 2 years

    Incidence and severity of adverse events

  2. 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

  3. Recommended Phase 2 Dose (RP2D)

    Time frame: up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Zhu, PhD

CONTACT

[email protected]

+86 13858065156

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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