A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to test the safety of TST003 in patients with cancer. The main question[s] it aims to answer are: - What is the recommended dose patients can safely receive? - How long does this drug remain in the body after administration? - What are the side effects of this drug? - Does your cancer respond to TST003? - Participants on this study will get TST003 intravenously (through a needle into your vein), once every 3 weeks. - You may need to come to the study site 2-4 times to have tests to see if you are eligible to be in the study before you begin to receive the study drug. - After you start the study drug, you will need to return to the site several times after each dose so the physician can take vital signs, draw blood samples, and evaluate you for safety and wellbeing. - Participants will continue taking the drug as long as they are receiving clinical benefit. - At the end of your study participation, additional testing is required.

Clinical Trial Description

Part 1 of the trial will consist cohorts, one dosed every 3 weeks at increasingly higher doses following the Bayesian Optimal Interval (BOIN) design. Part 1 is the dose finding portion of the trial. All locally advanced or metastatic solid tumors are accepted. 18 - 39 patients will be enrolled. Part 2 consists of 2 pharmacodynamic cohorts of approximately 26-36 patients respectively. For Part 2, participants must have locally advanced or metastatic colorectal cancer (CRC). The trial will last approximately 3 years, with assessments including but not limited to safety labs, ECGs, ECHO/MUGA, PKs and PDs and CT/MRI tumor assessments, and tumor biopsies based on emerging data found in Part 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05731271
Study type	Interventional
Source	Suzhou Transcenta Therapeutics Co., Ltd.
Contact	Lei Chen, MD
Phone	86-186-1679-7941
Email	lei.chen@transcenta.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	February 8, 2023
Completion date	August 2025

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