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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: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 01 Oct 2024

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At a glance

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

    • Most Recent Events

    • 06 Aug 2024 According to an Omega Therapeutics media release, Company expects to select recommended dose for expansion and initiate monotherapy and combination expansion cohorts in fourth quarter of 2024
    • 28 Mar 2024 According to an Omega Therapeutics media release, company have recently opened enrollment of Cohort 5 at a dose level of 0.3mg/kg and looking forward to sharing additional updates from this program throughout 2024. Company expects to report additional updated clinical data from monotherapy dose escalation in mid-2024. Company plans for expansion into monotherapy and combination settings in mid-2024.
    • 26 Sep 2023 According to an Omega Therapeutics media release, based on preliminary clinical data of this trial , OTX-2002 continues to advance in monotherapy dose escalation. Following the identification of a recommended dose, the Company expects to initiate expansion cohorts in monotherapy and in combination with standard of care therapies.

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