Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Other Hematological Malignancies With CD123 Expression

Study Identifier:
ORM-1153-01-001
CT.gov Identifier:
NCT07809906
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

The goal of this Phase 1 clinical trial is to understand whether a new experimental treatment, called ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) which have a particular protein (called Cluster of Differentiation 123 or CD123) on the cancer cell's surface. Phase 1 studies are designed to find a safe and effective dose.

Participants will be receiving ORM-1153 at the defined study frequency as an infusion into the vein. They will need to visit the clinic frequently during the first few months of treatment.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1 Dose Escalation
Read More
Drug: All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.
Drug: Drug: ORM-1153
Drug: Intravenous Infusion
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form.
  • * Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment.
  • * Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • * Adequate organ and coagulation function.
Exclusion criteria
  • Diagnosed with Acute Promyelocytic Leukemia.
  • * Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter).
  • * Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-1153.
  • * Total White Blood Cell count >25,000/µL.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Andrew Sochacki
Status
Will Be Recruiting
Condition(s) Treated at Site