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

ConditionCD123+ Acute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrum Therapeutics USA, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ORM-1153

    Drug

    Intravenous Infusion

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Part 1 Dose EscalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Optimal Biological Dose(s) of ORM-1153

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

Time frame
Approximately 24 months
2

Incidence of Dose Limiting Toxicities (DLTs)

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

Time frame
Approximately 24 months
3

Incidence of Treatment Emergent Adverse Events (TEAEs)

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

Time frame
Approximately 24 months

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orum Therapeutics USA, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: