Condition: Hepatocellular Carcinoma · Sponsor: Tvardi Therapeutics, Incorporated
The primary objectives of Cohort A Phase 1b and exploratory expansion are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TTI-101 as a single agent. The primary objectives of Cohort A Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 as a single agent in participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohort A Phase 2 are to assess response, progression, survival, and pharmacokinetics. The primary objectives of Cohorts B and C Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, or unresectable HCC and to determine the MTD and/or RP2D of TTI-101 when used in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C). The primary objectives of Cohorts B and C Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered in…
This description comes directly from the study's public registry record.
Kari Anne Rowland, MS · Please email · clinicaltrials@tvardi.com
Sara Manning · Please email · clinicaltrials@tvardi.com
Always discuss trial participation with your own doctor first.
| The Kirklin Clinic of University of Alabama Birmingham Hospital | Birmingham, Alabama, United States | Recruiting |
| University of California San Diego | La Jolla, California, United States | Completed |
| Norris Comprehensive Cancer Center | Los Angeles, California, United States | Recruiting |
| University of California Irvine Medical Center | Orange, California, United States | Recruiting |
| University of Colorado Hospital - Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C., District of Columbia, United States | Completed |
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland, United States | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor, Michigan, United States | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan, United States | Recruiting |
| Washington University in St. Louis | St Louis, Missouri, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center - New York | New York, New York, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05440708