Study on BC3402 with Tremelimumab and Durvalumab for Liver Cancer

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06608940

Provider View

This clinical trial is testing a new experimental treatment called BC3402, combined with the drugs tremelimumab and durvalumab, to see if it is safe and effective for patients with advanced liver cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment for advanced liver cancer, known as hepatocellular carcinoma (HCC). This treatment combines BC3402, an experimental drug, with two existing immunotherapy drugs, tremelimumab and durvalumab. These drugs work by helping the immune system attack cancer cells. The study is for patients who have not received prior treatment for their advanced liver cancer and are not eligible for surgery or other local treatments.

Description

Hepatocellular carcinoma (HCC) is a common type of liver cancer and a leading cause of cancer-related deaths. Current treatments using immune checkpoint inhibitors (ICIs) like tremelimumab and durvalumab have shown some success, but only about 20% of patients respond well. This study is exploring a new approach by adding BC3402, a drug that targets a protein called TIM3, which is involved in regulating the immune system. Researchers believe that targeting TIM3, along with PD1 and CTLA4, could improve treatment outcomes for patients with advanced HCC. The trial will test this combination in patients who have not received previous treatment for their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must provide written informed consent.
  • Have confirmed liver cancer (HCC) based on tissue analysis.
  • Have not received previous systemic therapy for advanced liver cancer.
  • Not eligible for local treatments like surgery or embolization.
  • Have a specific stage of liver cancer (BCLC stage B or C).
  • Have a Child-Pugh Score class A, indicating good liver function.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in strenuous activity but ambulatory.
  • If infected with Hepatitis B, must be on antiviral therapy to control the virus.
  • If infected with Hepatitis C, must have detectable virus levels.
  • Have at least one measurable tumor that can be tracked with scans.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Women must not be pregnant and must have a negative pregnancy test if of childbearing potential.
  • Must weigh less than 100 kg to receive a specific dose level.

Exclusion Criteria

  • Have unresolved side effects from previous cancer treatments, except for hair loss or skin conditions.
  • Have received another experimental treatment or local therapy within 28 days before starting the study.
  • Are currently receiving other cancer treatments.
  • Have allergies to any of the study drugs.
  • Have had major surgery within 28 days before starting the study.
  • Have a history of organ transplant or certain liver conditions.
  • Have uncontrolled high blood pressure or other serious health conditions.
  • Have active infections like tuberculosis or HIV.
  • Have received a live vaccine within 30 days before starting the study.
  • Are pregnant, breastfeeding, or not using effective birth control if of reproductive potential.
  • Have participated in previous studies with similar drugs.

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