AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Azacitidine

Criteria

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