Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Suresh
Balasubramanian, M.D.
Oncology - Hematology, Oncology - Medical View Profile

Primary Objectives:

To determine the safety and tolerability of each
protocol-specified ziftomenib combination in
patients with KMT2A-r or NPM1-m (± co-occurring
FLT3-m) R/R AML

Secondary Objectives:

To evaluate the antileukemic response for
ziftomenib combinations in patients with KMT2A-r
or NPM1-m (± co-occurring FLT3-m) R/R AML
based on the ELN 2022
To evaluate survival and disease control outcomes
for protocol-specified ziftomenib combinations in
patients with KMT2A-r or NPM1-m (± co-occurring
FLT3-m) R/R AML
To characterize the PK of ziftomenib and
metabolites when administered in combination with
SOC treatments in adults with R/R NPM1-m or
KMT2A-r AML
To evaluate the PK of gilteritinib when
administered concurrently with ziftomenib in adults
with R/R NPM1-m (+ co-occurring FLT3-m)

Eligibility

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.

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices