Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

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

Details

• Lead Sponsor: Kura Oncology, Inc.
• Treatments: Cytarabine; Fludarabine; Gilteritinib; Idarubicin; Lenograstim

Criteria

Key Inclusion Criteria:

• Has been diagnosed with relapsed/refractory AML.

• Has a documented NPM1 mutation or KMT2A rearrangement.

• Has a documented FLT3 mutation (cohort A-3 only).

• Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.

• Has adequate hepatic and renal function as defined per protocol.

• Has an ejection fraction above a protocol defined limit.

• Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.

• Has agreed to use contraception as defined per protocol.

Key Exclusion Criteria:

• Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.

• Has clinically active central nervous system leukemia.

• Has an active and uncontrolled infection.

• Has a mean corrected QT interval (QTcF) > 480ms.

• Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.

• Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy <14 days or within 5 drug half-lives prior to the first dose of study intervention.

• Has had major surgery within 4 weeks prior to the first dose of study intervention.

• Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.

• Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD.

• Participant is pregnant or lactating.