Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase 1 Clinical Study of QLS5132 Monotherapy in Advanced Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
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
Conditions
Interventions
QLS5132
antibody drug conjugate (ADC).
Locations (1)
Zhejiang Cancer Hospital
Hangzhou, China