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

Phase 1Not Yet RecruitingNCT07809906

Orum Therapeutics USA, Inc.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

CD123+ Acute Myeloid Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

START - Midwest

Grand Rapids, Michigan, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Incidence of Dose Limiting Toxicities (DLTs)

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

Time frame: Approximately 24 months

Incidence of Treatment Emergent Adverse Events (TEAEs)

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

Time frame: Approximately 24 months