A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
| Registry | NCT05211570 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; non randomized, sequential, masking: none, treatment |
| Enrollment | 78 (Estimated) |
| Sponsor | AB Science (Industry) |
| Conditions | Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia, in Relapse, Myelodysplastic Syndrome Acute Myeloid Leukemia |
| Interventions | AB8939, Venetoclax (Drug) |
| Dates | start 2022-06-01, primary completion 2026-08-01 (estimated), completion 2026-12-01 (estimated), first posted 2022-01-27, last updated 2025-10-02 |
| Locations | 10 sites in United States, France, Greece, Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Myeloid Leukemia Refractory All trials for Acute Myeloid Leukemia, in Relapse All trials of AB8939 All trials of Venetoclax
The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
This is a Phase 1/2, open-label, multi-center, non-randomized, 2-part study in patients with refractory and relapsed AML and refractory myelodysplastic syndrome.
Study AB18001 has a multi-stage design. The first part is a dose escalation study that aims to determine the safety, tolerability and pharmacokinetic profiles of consecutive daily intravenous administration of AB8939 in patients with refractory or relapsed AML or patients with refractory myelodysplastic syndrome, and to determine the recommended dose for the second-stage dose expansion study. This dose expansion study aims to determine the schedule for a Phase 2 trial in patients with relapsed/refractory AML and to also provide an early efficacy assessment of AB8939.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AB8939 | Experimental | Drug: AB8939 | AB8939 administered as a single agent |
| AB8939 plus Venetoclax | Experimental | Drug: AB8939; Drug: Venetoclax | AB8939 administered in combination with venetoclax |
Sex: All, ages: 18 Years to any
DOSE ESCALATION STUDY Key Inclusion Criteria: * Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. * Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system. * ECOG performance status ≤ 1 * Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * Patients diagnosed with acute promyelocytic leukemia (M3) * Patients with clinically active CNS leukemia * Patients with HSCT within 100 days prior to the first administration of AB8939 * Women who are lactating/breastfeeding or who plan to breastfeed while on study * Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply EXPANSION COHORT STUDY Key Inclusion Criteria: * Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. * ECOG performance status ≤ 2 * Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures * Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: * Patients eligible to a standard of care * Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion * Patients diagnosed with acute promyelocytic leukemia (M3) * Patients with clinically active CNS leukemia * Patients with HSCT within 100 days prior to the first administration of AB8939 * Women who are lactating/breastfeeding or who plan to breastfeed while on study * Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply
| Facility | City | Country | Status |
|---|---|---|---|
| MD Anderson Cancer Center | Houston, Texas | United States | Not yet recruiting |
| Institut Paoli Calmettes | Marseille | France | Not yet recruiting |
| National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit | Athens | Greece | Recruiting |
| General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante) | Alicante | Spain | Recruiting |
| Hospital San Pedro de Alcantara | Cáceres | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario Quirónsalud | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center Madrid | Madrid | Spain | Recruiting |
| Clínica Universidad de Navarra | Pamplona | Spain | Recruiting |
| Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) | Seville | Spain | Recruiting |