CD123+ Acute Myeloid Leukemia
Conditions
Keywords
Antibody Drug Conjugate, Protein-Degradation, GSPT1, CD123, AML, Hematologic Malignancies
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.
Interventions
DRUGORM-1153
Intravenous Infusion
Sponsors
Orum Therapeutics USA, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Biological Dose(s) of ORM-1153 | Approximately 24 months | Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153 |
| Incidence of Dose Limiting Toxicities (DLTs) | Approximately 24 months | Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Approximately 24 months | Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs |
Secondary
| Measure | Time frame |
|---|---|
| Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Study the anti-drug antibodies against ORM-1153 | Approximately 36 months |
| Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload | Approximately 36 months |
| Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload | Approximately 36 months |
| Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload | Approximately 36 months |
| CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
| Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s) | Approximately 36 months |
Countries
United States
Contacts
CONTACTOrum Therapeutics USA, Inc.
Outcome results
None listed