drugset / Trial / NCT03195764

Safety and Tolerability Study for T-1101 (Tosylate) to Treat Advanced Refractory Solid Tumors

NCT03195764 ↗

Phase 1 Terminated 21 enrolled Taivex Therapeutics Corporation
NaSingle-groupOpen-labelTreatment

Summary

T-1101 (Tosylate) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by Taivex Therapeutics Corp. T-1101 (Tosylate) is a potent anti-cancer agent in numerous human cancer cell lines. In addition, oral administration of T-1101 (Tosylate) showed tumor growth inhibition in different mouse xenograft models of human cancers. In this study, safety, tolerability and PK of T-1101 (Tosylate) will be evaluated and also the recommended dose and regimen(s) to initiate Phase 2 will be determined.

Timeline

Start
2017-09-14
Primary completion
2019-10-01
Completion
2019-10-23

Outcome

Outcome not reported

Stopped: “The study was terminated before the primary endpoint (determination of MTD) was reached because the OPC form is to be replaced with the newly developed capsule form in all subsequent clinical trials.”

Drugs

EvaluationDrugModalityDoseRoute
Subject T-1101 Small molecule — Oral