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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 and Other Solid Tumor Types Known for Association With the MYC Oncogene

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Trial Profile

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 and Other Solid Tumor Types Known for Association With the MYC Oncogene

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs OTX-2002 (Primary) ; Immune checkpoint protein inhibitors; Protein tyrosine kinase inhibitors
  • Indications Cervical cancer; Colorectal cancer; Liver cancer; Pancreatic cancer; Sarcoma; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms MYCHELANGELO I
  • Sponsors Omega Therapeutics

Most Recent Events

  • 03 Feb 2025 Status changed from recruiting to discontinued. Reason the study was stopped: Sponsor decision to terminate after monotherapy dose escalation.
  • 14 Nov 2024 According to an Omega Therapeutics media release, the company plans to present the Phase 1 dataset at an upcoming scientific conference.
  • 14 Nov 2024 According to an Omega Therapeutics media release, the phase 1 MYCHELANGELO trial of OTX-2002 has been completed and the Company is engaged in discussions with potential partners to further advance clinical development into Phase 2 or may choose to resume development through internal efforts with additional funding.

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