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TR128 in Patients With Advanced Solid Tumors
Sponsor: Tarapeutics Science Inc.
Summary
This is a open-label, 3+3 design, dose escalation and expansion, phase I study, to evaluate the safety and tolerability, and to determine the Recommended Phase II Dose (RP2D) of TR128 when administered qd in patients with advanced solid tumors. Up to 5 cohorts of 3-6 patients each will be treated in dose escalation phase of the study. One cycle is 28 days. Dose expansion phase to further evaluate the safety, tolerability and preliminary anti-tumor activity of TR128 at the RP2D.
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TR128 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-02-23
Completion Date
2025-12-30
Last Updated
2024-05-14
Healthy Volunteers
No
Conditions
Interventions
TR128
TR128 will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. Starting dose is 100mg, with escalation to 500mg.
Locations (3)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilonjiang, China
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China