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Study of TTI-101 for Advanced Liver Cancer

This study is testing a new oral medication called TTI-101 for people with locally advanced or metastatic (spread to other parts of the body), and unresectable (cannot be removed by surgery) hepatocellular carcinoma (HCC), a type of liver cancer. Researchers want to see how safe TTI-101 is, what side effects it might cause, and how well it works. TTI-101 will be given alone, and also in combination with other approved cancer drugs like pembrolizumab, atezolizumab, and bevacizumab. The study aims to find the best dose of TTI-101 and measure how many people respond to the treatment. You may be able to join if you are 18 or older and have a confirmed diagnosis of this type of liver cancer.

Study design
This is an interventional study with a planned enrollment of 193 participants. It will evaluate TTI-101 as a single agent and in combination with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to approximately 20 months for adverse events and up to approximately 18 months for serious adverse events and treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05440708

A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Tvardi Therapeutics, Incorporated
~193 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:TTI-101PembrolizumabAtezolizumabBevacizumab

At a glance

Recruiting sites
18 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AE)
Measured over Up to approximately 20 months
+2 more outcomes measured

Conditions

Hepatocellular Carcinoma

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Hepatocellular Carcinoma

NCT05440708

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • DHR Health Institute for Research and Development

    McAllen, Texasstudy coordinator listed

    Recruiting

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Norris Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Summit Cancer Centers - North Spokane

    Spokane, Washingtonstudy coordinator listed

    Recruiting

  • The Kirklin Clinic of University of Alabama Birmingham Hospital

    Birmingham, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kari Anne Rowland, MS
[email protected]
Please email
Email the study team

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L (1500/μL) without granulocyte colony-stimulating factor support.
Lymphocyte count ≥0.5 × 10\^9/L (500/μL).
Platelet count ≥75 × 10\^9/L (75,000/μL) without transfusion.
Hemoglobin ≥90 g/L (9 g/dL). Participants may be transfused to meet this criterion.
Serum albumin ≥28 g/L (2.8 g/dL).
AST, ALT, and alkaline phosphatase (ALP) ≤5 × upper limit of normal (ULN).
Serum bilirubin ≤2 mg/dL.
Adequate renal function defined as either:
creatinine clearance ≥40 mL/min calculated using the Cockcroft-Gault formula, or
24-hour urine collection. 9. Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) ≤2 × ULN, except for participants receiving anticoagulation therapy. 10. Child-Pugh class A or B7 within 7 days prior to enrollment. 11. Females of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must:
Have a negative serum pregnancy test at screening.
Not be breastfeeding or lactating.
Agree to use a highly effective method of birth control for the duration of the study and for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices, or permanent sterilization. 12. Males must:
Agree to use a condom for at least 30 days after the last dose in the study even if vasectomized in order to prevent delivery of the drug via seminal fluid.
Agree to abstain from sperm donation through 30 days after administration of the last dose of the study treatment.
Unless surgically sterile, males with female partners of childbearing potential must agree to use 2 methods of acceptable birth control for at least 30 days after the last dose in the study. Effective forms of birth control include barrier methods used in conjunction with a spermicidal agent (according to standard local practices), nonhormonal intrauterine devices in female partners, or permanent sterilization.

Exclusion

Chronic pancreatitis.
Active untreated or uncontrolled fungal, bacterial, or viral infections (including COVID-19), sepsis, etc.
Acute and chronic, active infectious disorders including viral and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy. 24. Is unable to understand and to comply with study instructions and requirements.
Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, participants with psoriatic arthritis are excluded) are eligible for the study provided all of the following conditions are met:
Rash must cover \<10% of body surface area.
Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months. 39. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 40. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor α \[TNF-α\] agents) within 2 weeks prior to initiation of study treatment. Participants receiving low-dose corticosteroids (equivalent of prednisone 10 mg/day or lower) or who receive pulse corticosteroids due to intravenous (IV) contrast allergy are not excluded. 41. Active tuberculosis. 42. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. 43. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 44. Prior allogeneic stem cell or solid organ transplantation. 45. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.

What this trial measures

  • Incidence of Adverse Events (AE)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)Up to approximately 18 months
  • Phase 2: Overall Response Rate (ORR) to TTI-101Up to approximately 18 months

    ORR (calculated as Partial Response \[PR\] + Complete Response \[CR\]) using RECIST Version 1.1.