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NCT05440708 · ClinicalTrials.gov registry record · Phase 1
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
A Phase 1 study of Hepatocellular Carcinoma, sponsored by Tvardi Therapeutics, Incorporated.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 178
- Enrollment target
- 20
- Study locations
NCT05440708: Recruiting Phase 1 study of Hepatocellular Carcinoma, sponsored by Tvardi Therapeutics, Incorporated.
NCT05440708 is a Phase 1 study of Hepatocellular Carcinoma that is actively recruiting participants, run by Tvardi Therapeutics, Incorporated. The registered enrollment target is 178 participants, below the 256-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05440708, a Phase 1 study of Hepatocellular Carcinoma, is actively recruiting participants, sponsored by Tvardi Therapeutics, Incorporated.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 178 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of Cohort A Phase 1b 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 r
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Any clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations will be recorded as AEs.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Bevacizumab
- DRUG Atezolizumab
- DRUG TTI-101
Study Locations (20)
Texas
- Harold C. Simmons Comprehensive Cancer Center - Dallas
- DHR Health Institute for Research & Development - Edinburg
- University of Texas MD Anderson Cancer Center - Houston
- University of Texas Health Science Center - San Antonio - San Antonio
California
- University of California San Diego - La Jolla
- Norris Comprehensive Cancer Center - Los Angeles
- University of California Irvine Medical Center - Orange
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
- Barbara Ann Karmanos Cancer Institute - Detroit
Washington
- Virginia Mason Medical Center - Seattle
- Summit Cancer Centers - North Spokane - Spokane
Alabama
- The Kirklin Clinic of University of Alabama Birmingham Hospital - Birmingham
Colorado
- University of Colorado Hospital - Anschutz Medical Campus - Aurora
District of Columbia
- Georgetown Lombardi Comprehensive Cancer Center - Washington D.C.
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2027-06-28 |
| Phase | Phase 1 |
What NCT05440708 shows while recruiting
NCT05440708 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT05440708 names 20 study sites across 13 states, led by Texas, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05440708 about?
NCT05440708 is a clinical study titled "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 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 recom...
What is the current status of trial NCT05440708?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 178 participants. The study started on 2023-03-23. Estimated completion is 2027-06-28.
What conditions does trial NCT05440708 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT05440708?
The interventions under investigation include: Pembrolizumab (DRUG), Bevacizumab (DRUG), Atezolizumab (DRUG), TTI-101 (DRUG).
Who is sponsoring clinical trial NCT05440708?
This trial is sponsored by Tvardi Therapeutics, Incorporated, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05440708 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05440708's enrollment target sits among peer trials
178 45th of 145 higher than 101 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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