Recruiting
Phase 1

ORM-1153

Sponsor:

Orum Therapeutics USA, Inc.

Code:

NCT07809906

Conditions

CD123+ Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ORM-1153

Study Details

Brief 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.

Conditions

CD123+ Acute Myeloid Leukemia

Study ID

NCT07809906

Start date

Sep 23, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation

All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.

Interventions

ORM-1153

Intravenous Infusion

Primary outcome measure

  • Optimal Biological Dose(s) of ORM-1153 [ Time Frame: Approximately 24 months ]
  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Approximately 24 months ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Approximately 24 months ]

Central Contacts and Locations

Central contacts

Orum Therapeutics USA, Inc.

617-714-9597ClinicalTrials@orumrx.com

Locations

START - Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Andrew Sochacki, MD

616-389-6346information@startresearch.com

More Information

Sponsor

Orum Therapeutics USA, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • Antibody Drug Conjugate
  • Protein-Degradation
  • GSPT1
  • CD123
  • AML
  • Hematologic Malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Orum Therapeutics USA, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.