A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
Public ClinicalTrials.gov record NCT05440708. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05440708
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 193 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 22, 2023
- Primary completion
- Jan 31, 2027
- Completion
- Mar 9, 2027
- Last update posted
- Apr 26, 2026
2023 – 2027
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirklin Clinic of University of Alabama Birmingham Hospital | Birmingham | Alabama | 35233 | Recruiting |
| University of California San Diego | La Jolla | California | 92093 | Completed |
| Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| University of California Irvine Medical Center | Orange | California | 92868 | Recruiting |
| University of Colorado Hospital - Anschutz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | Completed |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | Recruiting |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Washington University in St. Louis | St Louis | Missouri | 63129 | Recruiting |
| Memorial Sloan Kettering Cancer Center - New York | New York | New York | 10065 | Recruiting |
| Cleveland Clinic Lerner College of Medicine | Cleveland | Ohio | 44195 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4000 | Recruiting |
| DHR Health Institute for Research and Development | McAllen | Texas | 78504 | Recruiting |
| University of Texas Health Science Center - San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | Recruiting |
| Summit Cancer Centers - North Spokane | Spokane | Washington | 99208 | Recruiting |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05440708, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2026 · Synced Sep 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05440708 live on ClinicalTrials.gov.