A Phase 1 Study of ORM-5029 in People With HER2-Positive Breast Cancer

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Full Title

Phase I Multicenter, Open-Label, First-in-Human Study of ORM-5029 in Subjects with HER2-Expressing Advanced Solid Tumors

Purpose

Researchers want to find the best dose of ORM-5029 for people with advanced breast cancer that makes the HER2 protein. ORM-5029 may be useful in people who cannot receive other HER2-targeted treatments or whose cancer keeps growing with these drugs. ORM-5029 works in a different way than those drugs. It is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have HER2-positive advanced breast cancer that cannot be successfully treated with other HER2-targeted drugs, or has grown despite treatment with those drugs.
  • Have completed any prior anti-cancer medications and radiation therapy at least 2 weeks before getting ORM-5029.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Joshua Drago’s office at 646-888-6971.

Protocol

24-218

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05511844