At a glance
ClinicalIndex Comparison Record- ✓Able to understand and provide informed consent and comply with study procedures
- ✓Age 18 years or older at informed consent
- ✓Histologically or radiographically confirmed (LIRADS category 5) locally advanced or metastatic unresectable HCC
- ✓Histological confirmation required for participants without cirrhosis
- ✕Pregnant or breastfeeding
- ✕Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- ✕History of leptomeningeal disease
- ✕Previous treatment with STAT inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
REVERT- Liver Cancer: A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating TTI-101, Pembrolizumab, and 2 other interventions for Hepatocellular Carcinoma. Currently recruiting, targeting 193 participants across 21 sites.
Signals
Detailed Summary
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 combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohorts B and C Phase 2 are to assess response, progression, survival, and pharmacokinetics.
Study Details
Timeline
Interventions
Oral tablet
Intravenous (IV) infusion
Intravenous (IV) infusion
Intravenous (IV) infusion