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RECRUITING
NCT05751356
PHASE1

TR128 in Patients With Advanced Solid Tumors

Sponsor: Tarapeutics Science Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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