Study on Tegavivint (BC2059) for Patients with Advanced Liver Cancer

Sponsor: Iterion Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05797805

Provider View

This clinical trial is testing a new drug, Tegavivint, for patients with advanced liver cancer who have not responded to previous treatments. The study will also explore combining Tegavivint with another drug, Pembrolizumab, to see if it improves outcomes.

Patient Parameters

Program Overview

The study is divided into two parts. The first part tests different doses of Tegavivint alone to find the best dose for patients with advanced liver cancer who have already tried other treatments. The second part will test Tegavivint combined with Pembrolizumab, a drug that helps the immune system fight cancer, to see if this combination works better.

Description

This study is for patients with advanced liver cancer (hepatocellular carcinoma) who have not improved after trying at least one other treatment. In the first part of the study, patients will receive Tegavivint alone to find the safest and most effective dose. This involves gradually increasing the dose to see how much patients can tolerate. Once the best dose is found, more patients will receive this dose to confirm its effectiveness.

In the second part, the study will test Tegavivint combined with Pembrolizumab in patients with specific genetic mutations (CTNNB1 or AXIN1) who have previously been treated with a PD-1/PD-L1 inhibitor. This part will also start with a dose increase to find the best combination dose. After that, patients will be randomly assigned to receive different doses to determine the most effective combination.

The study aims to find out if these treatments can help control liver cancer and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced liver cancer (HCC).
  • Have specific genetic mutations (AXIN1 or CTNNB1), except in the first part of the study.
  • Have cancer that has progressed after at least one previous treatment.
  • Have measurable cancer that can be tracked.
  • Be willing to provide tumor samples for testing.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate organ and blood function as shown by specific tests.
  • Have controlled blood pressure.
  • Have completed any previous cancer treatments and recovered from side effects.
  • Women of childbearing potential must agree to use effective contraception during the study and for four months after.

Exclusion Criteria

  • Have a different type of liver cancer or other cancers.
  • Are taking other cancer treatments or experimental drugs.
  • Have allergies to similar drugs.
  • Have uncontrolled illnesses or infections.
  • Have significant heart problems or recent heart attacks.
  • Have had major surgery recently.
  • Are pregnant or breastfeeding.
  • Are HIV-positive and on antiretroviral therapy.
  • Have received a live vaccine recently.
  • Have an autoimmune disease requiring treatment in the past two years.
  • Have a history of lung disease requiring steroids.
  • Have had an organ or bone marrow transplant.

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