NCT06001788
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Clinical Operations - Role: CONTACT - Phone: 617-588-3755 - Email: KO-MEN-008@kuraoncology.com
PHASE1
RECRUITING
NCT06001788
INTERVENTIONAL
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
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.
Key Inclusion Criteria:
* Has been diagnosed with relapsed/refractory AML.
* Has a documented NPM1 mutation or KMT2A rearrangement.
* Has a documented FLT3 mutation (cA-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.
AML
AML With Mutated NPM1
Hematologic Malignancy
KMT2Ar
NPM1 Mutation
MLL Rearrangement
Leukemia
Acute Myeloid Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute Leukemia
Neoplasms by Histologic Type
- TREATMENT
-
- Type: DRUG
- Name: Ziftomenib
- Description: Oral administration
- Arm Group Labels: Phase 1a, Phase 1b
-
- Type: DRUG
- Name: Fludarabine
- Description: Intravenous infusion
- Arm Group Labels: Phase 1a, Phase 1b
-
- Type: DRUG
- Name: Idarubicin
- Description: Intravenous infusion
- Arm Group Labels: Phase 1a, Phase 1b
-
- Type: DRUG
- Name: Cytarabine
- Description: Intravenous Infusion
- Arm Group Labels: Phase 1a, Phase 1b
-
- Type: DRUG
- Name: Gilteritinib
- Description: Oral administration
- Arm Group Labels: Phase 1a, Phase 1b
-
- Type: BIOLOGICAL
- Name: Granulocyte colony-stimulating factor
- Description: Subcutaneous injection
- Arm Group Labels: Phase 1a, Phase 1b
- Kura Oncology, Inc.