A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

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 unresectabl

Trial Details

NCT ID
NCT05440708
Phase
PHASE1 / PHASE2
Sponsor
Tvardi Therapeutics, Incorporated
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • TTI-101
  • Pembrolizumab
  • Atezolizumab
  • Bevacizumab
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
  • Age ≥18 years at the time of informed consent.
  • Have histologically or radiographically (Liver Imaging Reporting and Data Systems category 5) confirmed diagnosis of locally advanced or metastatic…
  • Cohorts A and B only: Willing to provide a representative fresh tumor tissue specimen prior to enrollment. The fresh tumor specimen must be obtaine…

For full eligibility, visit ClinicalTrials.gov.

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