QLS5132 Combination Therapy in Advanced Solid Tumors

NCT07453394 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS5132-201
• Study Type: interventional
• Target: 626
• Locations: 0 countries
• Sites: N/A

Brief 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

Gastric Cancer (GC); Non-small Cell Lung Cancer (NSCLC); Endometrial Cancer; Advanced Solid Tumors; Ovarian Cancer

Keywords

CLDN6 ADC

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events

  Incidence and severity of adverse events

  up to 2 years

• Maximum tolerated dose (MTD)

  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)

  up to 2 years

Study Arms (5)

QLS5132 combined wtih bevacizumab

EXPERIMENTAL

QLS5132 in combination with bevacizumab

Drug: QLS5132; Bevacizumab

QLS5132 combined wtih platinum

EXPERIMENTAL

QLS5132 in combination with platinum, followed by sequential QLS5132 alone or in combination with bevacizumab

Drug: QLS5132; Platinum; Bevacizumab

QLS5132 combined wtih Olaparib

EXPERIMENTAL

QLS5132 in combination with Olaparib, followed by sequential QLS5132 alone or in combination with bevacizumab

Drug: QLS5132; Olaparib; Bevacizumab

QLS5132 combined wtih immune checkpoint inhibitors

EXPERIMENTAL

QLS5132 in combination with immune checkpoint inhibitors

Drug: QLS5132; QL1706; QL2107

QLS5132 combined with immune checkpoint inhibitors and chemotherapy

EXPERIMENTAL

QLS5132 in combination with immune checkpoint inhibitors and chemotherapy

Drug: QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin

Interventions

QLS5132; Bevacizumab DRUG

Intravenous infusion，Q3W

QLS5132 combined wtih bevacizumab

QLS5132; Platinum; Bevacizumab DRUG

Intravenous infusion，Q3W

QLS5132 combined wtih platinum

QLS5132; Olaparib; Bevacizumab DRUG

Olaparib is oral; all others are intravenous infusion，Q3W

QLS5132 combined wtih Olaparib

QLS5132; QL1706; QL2107 DRUG

Intravenous infusion，Q3W

QLS5132 combined wtih immune checkpoint inhibitors

QLS5132; QL1706; QL2107; Carboplatin; Cisplatin; Oxaliplatin DRUG

Intravenous infusion，Q3W

QLS5132 combined with immune checkpoint inhibitors and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Stomach Neoplasms; Carcinoma, Non-Small-Cell Lung; Endometrial Neoplasms; Ovarian Neoplasms

Interventions

Bevacizumab; Platinum; olaparib; Carboplatin; Cisplatin; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Tao Zhu, PhD

CONTACT

+86 13858065156; zhutao@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03