Study of TTI-101 Alone and in Combination for Advanced Liver Cancer

Sponsor: Tvardi Therapeutics, Incorporated

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05440708

Provider View

This clinical trial is testing a new drug, TTI-101, both by itself and with other treatments, to see if it is safe and effective for people with advanced liver cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to find out if TTI-101, taken as a pill, is safe and well-tolerated in people with advanced liver cancer that cannot be surgically removed. It will also determine the best dose for future studies. The trial will test TTI-101 alone and in combination with other cancer drugs like pembrolizumab, atezolizumab, and bevacizumab. Researchers will look at how well the treatment works, how the cancer responds, and how long patients survive.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and agree to the study requirements.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of advanced liver cancer that cannot be removed by surgery.
  • For some groups, must provide a fresh tumor sample after previous treatment.
  • Must have measurable cancer according to specific criteria.
  • Must be able to swallow pills.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have adequate blood and organ function based on specific lab tests.
  • Must have a Child-Pugh class A or B7 liver function score.
  • Women of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective birth control during the study and for 30 days after.
  • Men must agree to use a condom and not donate sperm for 30 days after the study.
  • Specific criteria for different groups:
    • Cohort A: Must have shown cancer progression after up to 3 previous treatments.
    • Cohort B: Must have shown cancer progression after at least 2 cycles of previous treatment with certain drugs.
    • Cohort C: Must not have had previous systemic treatment for advanced liver cancer and must have had a recent evaluation for varices.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Certain types of liver cancer or mixed liver and bile duct cancer.
  • History of certain brain diseases or previous treatment with specific cancer drugs.
  • Recent treatment with certain cancer therapies or investigational drugs.
  • Extensive previous radiation therapy or bone marrow transplant.
  • Use of certain herbal medications.
  • Not fully recovered from COVID-19 symptoms.
  • Recent major surgery or ongoing side effects from surgery.
  • Significant heart problems or fluid buildup requiring frequent drainage.
  • Recent stroke or brain issues.
  • Uncontrolled high calcium levels or bleeding disorders.
  • Severe allergic reactions to similar drugs.
  • Active brain metastases or difficulty swallowing pills.
  • History of HIV or certain viral infections.
  • Recent other cancers, except for certain low-risk types.
  • Severe uncontrolled medical conditions.
  • Specific criteria for different groups:
    • Cohort B: Must not have stopped previous treatment with certain drugs for reasons other than cancer progression.
    • Cohort C: Must not have uncontrolled high blood pressure or recent use of certain medications.

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