Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Conditions Studied

Hepatocellular Carcinoma

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

FieldValue
Enrollment Target 178 participants
Start Date 2023-03-23
Est. Completion 2027-06-28
Phase Phase 1

Sponsor

Tvardi Therapeutics, Incorporated

4 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05440708

The ClinicalTrials.gov registry entry for NCT05440708 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 256-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (30% lower). The listed sponsor is Tvardi Therapeutics, Incorporated, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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

Similar trials for Hepatocellular Carcinoma

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.

Explore more on PlainTrial

Hepatocellular Carcinoma

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.