OTX-2002 for Liver Cancer
(MYCHELANGELO I Trial)
Trial Summary
What is the purpose of this trial?
This is a Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma (HCC) and other solid tumor types known for association with the MYC oncogene. The study consists of Part 1 (OTX-2002 monotherapy) and Part 2 (OTX-2002 combined with standard of care in hepatocellular carcinoma). Part 1 consists of escalation and expansion, and Part 2 consists of safety run-in and expansion. The objective of Part 1 escalation and Part 2 safety run-in will be safety and tolerability, while anti-tumor activity will be evaluated as the primary endpoint in Part 1 and Part 2 expansion.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, if you have chronic hepatitis B, you must continue antiviral therapy for at least 12 weeks before starting the study drug.
What data supports the idea that OTX-2002 for Liver Cancer is an effective treatment?
The available research does not provide specific data on the effectiveness of OTX-2002 for Liver Cancer. Instead, it focuses on liver transplantation and other treatments for liver cancer, such as hepatic resection and systemic therapies. These studies show improved survival rates for liver transplantation over the years and compare it to other treatments, but they do not mention OTX-2002. Therefore, there is no direct evidence from the provided information to support the effectiveness of OTX-2002 for Liver Cancer.12345
What safety data is available for OTX-2002 in liver cancer treatment?
The provided research does not contain specific safety data for OTX-2002 or OTX 2002 in liver cancer treatment. The articles focus on general topics such as radiation oncology toxicity, immune-related adverse events in PD-1 blockade immunotherapy, adverse event reporting in cancer trials, liver injury in pediatric oncology, and real-time toxicity monitoring in clinical trials. None of these directly address safety data for OTX-2002.678910
Research Team
Yan Moore, MD
Principal Investigator
Omega Therapeutics
Eligibility Criteria
Adults over 18 with advanced liver cancer (hepatocellular carcinoma) or solid tumors linked to the MYC gene, who've tried standard treatments without success. They must have a good performance status and controlled hepatitis B if present. Those with severe liver complications, brain metastases, recent bleeding from esophageal varices, or specific types of mixed liver cancers cannot join.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- OTX-2002
OTX-2002 is already approved in United States for the following indications:
- Hepatocellular carcinoma (Orphan Drug Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Omega Therapeutics
Lead Sponsor