Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

NCT ID: NCT06932094

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-02-29

Brief Summary

The Phase 1 trial includes Phase 1a (dose-escalation) and Phase 1b (dose-expansion):

• Phase 1a: Assesses safety, tolerability, PK, and preliminary efficacy of QLS5132 in advanced solid tumors using ATD + BOIN, given IV every 3 weeks. Up to 12 subjects may be enrolled in promising dose levels.
• Phase 1b: Evaluates QLS5132's anti-tumor efficacy in specific CLDN6-positive solid tumors, including ovarian cancer, NSCLC, gastric cancer, and others. Expansion studies at 1~3 selected dose levels follow successful Phase 1a results.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Finding and Expansion- QLS5132 Monotherapy

Intravenous infusion，Q3W

Group Type: EXPERIMENTAL

QLS5132

Intervention Type: DRUG

antibody drug conjugate (ADC).

Interventions

QLS5132

antibody drug conjugate (ADC).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Advanced solid tumors;
• Measurable disease, per RECIST 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 NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral;

Exclusion Criteria

• Previous treatment with drugs targeting CLDN6 (including 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 AML;
• History of other active malignant tumors within 3 years before signing the informed consent form;
• If female, is pregnant or breastfeeding;
• Be allergic to any component of QLS5132 or its excipients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, , China

Countries

China

Central Contacts

Tao Zhu, PhD

Role: CONTACT

zhutao@zjcc.org.cn

13858065156

Zhengbo Song, PhD

Role: CONTACT

songzb@zjcc.org.cn

13857153345

Facility Contacts

Tao Zhu

Role: primary

Other Identifiers

QLS5132-101

Identifier Type: -

Identifier Source: org_study_id