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A Study of QLS5133 Monotherapy in Advanced Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion: * Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion. * Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.
Official title: A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2025-07
Completion Date
2028-04
Last Updated
2025-07-11
Healthy Volunteers
No
Conditions
Interventions
QLS5133
antibody drug conjugate (ADC)
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China