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NOT YET RECRUITING
NCT06932094
PHASE1

Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5132 Monotherapy in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2025-05

Completion Date

2028-02

Last Updated

2025-04-23

Healthy Volunteers

No

Interventions

DRUG

QLS5132

antibody drug conjugate (ADC).

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, China