A Phase 1/2 Study to Evaluate OTX-2002 in Patients with Hepatocellular Carcinoma and Other Solid Tumor Types Known for Association with the MYC Oncogene
Stopped early · Phase 1/Phase 2
Conditions studied: Hepatocellular Carcinoma, Solid Tumor, Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Recurrent, Hepatocellular Cancer, Liver Cancer, Liver, Cancer Of, Non-Resectable
In brief
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.
Key facts
- Study ID
- NCT05497453
- Run by
- Omega Therapeutics
- People needed
- 24
- Starts
- 2022-08-19
- Expected to finish
- 2024-11-21
- Last updated by the study team
- 2025-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- University of Florida Health Cancer Center — Gainesville, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- Stephenson Cancer Center at Oklahoma University — Oklahoma City, Oklahoma, United States
- Fred Hutch / University of Washington — Seattle, Washington, United States
- Prince of Wales Hospital — Hong Kong, Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong
- National Cancer Center Singapore — Singapore, Singapore
- National University Hospital — Singapore, Singapore
- Asan Medical Center — Seoul, South Korea
- Seoul National University Hospital — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
- National Cheng Kung University Hospital — Tainan, Taiwan
- National Taiwan University Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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