TT-4 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.

Clinical Trial Description

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-4 in subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-4 in subjects with advanced subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, antitumor activity, and efficacy of TT-4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04976660
Study type	Interventional
Source	Tarus Therapeutics, Inc.
Contact	Sushant Kumar, PhD
Phone	+1862-202-9510
Email	skumar@tarustx.com
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	December 15, 2022
Completion date	September 30, 2023

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