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Spots Global Cancer Trial Database for TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

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Trial Identification

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

Official Title: Phase I/II First-in-Human Study of TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Study ID: NCT04969315

Interventions

TT-10

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

University of California San Francisco UCSF, San Francisco, California, United States

Sarah Cannon Research Institute Denver, Denver, Colorado, United States

Norton Cancer Institute, Louisville, Kentucky, United States

Washington University, Saint Louis, Missouri, United States

Jefferson Health-Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Virginia Cancer Specialists, Fairfax, Virginia, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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