NCT05440708 · Tvardi Therapeutics, Incorporated
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
What this study is about
The primary objectives of group of participants A Phase 1b are to evaluate the safety and how well patients handle the treatment of TTI-101 taken by mouth 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 group of participants A Phase 2 are to evaluate the safety and how well patients handle the treatment of TTI-101 taken by mouth administered as a single agent at the
View original scientific description
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.
Interventions
DRUG
TTI-101
Oral tablet
DRUG
Pembrolizumab
Intravenous (IV) infusion
DRUG
Atezolizumab
Intravenous (IV) infusion
DRUG
Bevacizumab
Intravenous (IV) infusion
Primary outcome measures
Incidence of Adverse Events (AE)
Time frame: Up to approximately 20 months
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.
Incidence of Serious Adverse Events (SAE)
Time frame: Up to approximately 18 months
Phase 2: Overall Response Rate (ORR) to TTI-101
Time frame: Up to approximately 18 months
ORR (calculated as Partial Response \[PR\] + Complete Response \[CR\]) using RECIST Version 1.1.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions. 2. Age ≥18 years at the time of informed consent. 3. Have histologically or radiographically (Liver Imaging Reporting and Data Systems category 5) confirmed diagnosis of locally advanced or metastatic, and unresectable HCC. Participants without cirrhosis require histological confirmation. 4. Cohorts A and B only: Willing to provide a representative fresh tumor tissue specimen prior to enrollment. The fresh tumor specimen must be obtained after progression on the prior therapy. No biopsy is required for participants in Cohort C. 5. Measurable disease as per RECIST Version 1.1. Participants who received prior local therapy are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST Version 1.1. 6. A
Where
- Birmingham, Alabama
- La Jolla, California
- Los Angeles, California
- Orange, California
- Aurora, Colorado
- Washington D.C., District of Columbia
- Tampa, Florida
- Baltimore, Maryland
- Ann Arbor, Michigan
- Detroit, Michigan
- St Louis, Missouri
- New York, New York
And 9 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations