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NCT Number: NCT07809906

Study of ORM-1153 in Acute Myeloid Leukemia (AML) With CD123 Expression

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.

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Key information

Conditions

CD123+ Acute Myeloid Leukemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

START - Midwest, Grand Rapids, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ORM-1153

Drug

Intravenous Infusion

Primary outcomes

  1. Optimal Biological Dose(s) of ORM-1153

    Time frame: Approximately 24 months

    Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153

  2. Incidence of Dose Limiting Toxicities (DLTs)

    Time frame: Approximately 24 months

    Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs

  3. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Approximately 24 months

    Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload

    Time frame: Approximately 36 months

  2. Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload

    Time frame: Approximately 36 months

  3. Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload

    Time frame: Approximately 36 months

  4. Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  5. Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  6. Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  7. CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  8. Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  9. Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  10. Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  11. Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  12. GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s)

    Time frame: Approximately 36 months

  13. Study the anti-drug antibodies against ORM-1153

    Time frame: Approximately 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Orum Therapeutics USA, Inc.

CONTACT

[email protected]

617-714-9597

Sponsors and collaborators

Lead sponsor

Orum Therapeutics USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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