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Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.
Official title: A Phase I Clinical Study to Evaluate Safety, Tolerability, PK Characteristic and Preliminary Efficacy of QLS-1304 in Patients With Advanced Malignant Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-03-06
Completion Date
2027-12
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
QLS1304 tablet
QLS1304 monotherapy dose escalation and expansion
Locations (1)
Fudan University Cancer Hospital
Shanghai, China