Study on OTX-2002 for Liver Cancer and Other Tumors Linked to the MYC Gene

Sponsor: Omega Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05497453

Provider View

This clinical trial is testing a new drug, OTX-2002, to see if it is safe and effective for treating liver cancer and other tumors associated with the MYC gene. The study will look at OTX-2002 alone and in combination with standard treatments.

Patient Parameters

Program Overview

The study is divided into two parts. Part 1 tests OTX-2002 by itself, while Part 2 tests it with standard treatments for liver cancer. The main goals are to check the safety and effectiveness of OTX-2002 in shrinking tumors. Part 1 will focus on finding the right dose and observing any side effects, while Part 2 will see how well the drug works with other treatments.

Description

This study is exploring a new drug called OTX-2002 for treating liver cancer and other tumors linked to the MYC gene. It is divided into two parts:

  • Part 1: This part tests OTX-2002 alone. It starts with a phase where the dose is gradually increased to find the safest and most effective amount. Patients with liver cancer or other tumors that have not responded to standard treatments will receive OTX-2002 through an IV. The main focus is to see how safe the drug is and to find the best dose. After finding the right dose, more patients will be treated to see how well the drug works in shrinking tumors.

  • Part 2: This part tests OTX-2002 in combination with standard treatments for liver cancer. Initially, a small group of patients will receive the combination to ensure it is safe. If it is, more patients will be treated to see how effective the combination is in reducing tumors. The study will look at how long the tumors respond to the treatment and any side effects that occur.

The study aims to provide new insights into treating liver cancer and other MYC-related tumors, potentially offering new options for patients who have limited treatment choices.

Eligibility Criteria

Key inclusion

  • Participants with metastatic, advanced (non-resectable), or recurrent solid tumor who progressed on, relapsed after, are refractory to, or intolerant of standard of care (only applicable to Part 1 escalation)
  • Participants with BCLC Stage B (intermediate stage) or C (advanced stage), Child-Pugh A hepatocellular carcinoma who is not amenable to locoregional therapy, refractory to locoregional therapy or not amenable to curative treatment approach
  • Adult participants age ≥ 18 years at the time of signing informed consent
  • Participant must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, and without available subsequent standard of care
  • Participants with chronic hepatitis B must have received antiviral therapy for hepatitis B virus (HBV) for at least 12 weeks and HBV viral load must be < 500 IU/mL prior to first dose of study drug.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion

  • Mixed histology cholangiocarcinoma and HCC, or fibrolamellar variant HCC
  • Hepatocellular carcinoma with ≥ 50% liver occupation
  • Clear invasion into the bile duct
  • Portal vein invasion with Vp4
  • Active/untreated CNS metastases or carcinomatous meningitis
  • History of ascites requiring paracentesis within the past 3 months
  • Esophageal or gastric variceal bleeding in the past 3 months
  • History of hepatic encephalopathy in the past 3 months.

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