TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-10 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-10.

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-10 in subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); 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-10 in subjects with advanced subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); 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, anti-tumor activity, and efficacy of TT-10. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Renal Cell
Castrate Resistant Prostate Cancer
Head and Neck Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Renal Cell Cancer
Squamous Cell Carcinoma of Head and Neck

Clinical Trial Details

NCT number	NCT04969315
Study type	Interventional
Source	Portage Biotech
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	June 23, 2023
Completion date	August 14, 2025

View Details

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