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Ziftomenib

DRUG18 trials

Sponsors

Prinses Maxima Centrum voor Kinderoncologie B.V., Kura Oncology Inc., Kura Oncology, Inc., Tanja Andrea Gruber, PedAL BCU, LLC

Conditions

AMLAML With Mutated NPM1Acute LeukemiaAcute Leukemia of Ambiguous LineageAcute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia, With Appropriate MutationsAcute Lymphocytic LeukemiaAcute Myeloid Leukemia

Phase 1

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
RecruitingNCT04067336
Kura Oncology, Inc.Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia +4
Start: 2019-09-12End: 2028-10-16Target: 263Updated: 2025-11-10
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
RecruitingNCT05735184
Kura Oncology, Inc.Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Recurrent +7
Start: 2023-07-18End: 2030-04-01Target: 420Updated: 2026-03-13
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
RecruitingNCT05848687
Tanja Andrea GruberLymphoblastic Leukemia
Start: 2023-11-03End: 2033-12-31Target: 90Updated: 2026-01-13
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
RecruitingNCT06001788
Kura Oncology, Inc.Acute Leukemia, Acute Myeloid Leukemia, AML +9
Start: 2024-02-22End: 2027-08-31Target: 171Updated: 2025-12-03
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
RecruitingNCT06376162
PedAL BCU, LLCRelapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia
Start: 2025-03-18End: 2027-01-31Target: 20Updated: 2025-10-20
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias
RecruitingNCT06397027
M.D. Anderson Cancer CenterPediatric Relapsed, Refractory Acute Leukemia
Start: 2024-12-27End: 2030-12-31Target: 22Updated: 2026-01-29
Ziftomenib Maintenance Post Allo-HCT
RecruitingNCT06440135
Massachusetts General HospitalAcute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, KMT2A Rearrangement +1
Start: 2024-06-11End: 2027-09-01Target: 22Updated: 2026-03-19
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia
RecruitingNCT06448013
M.D. Anderson Cancer CenterAcute Myeloid Leukemia
Start: 2025-03-07End: 2030-12-31Target: 22Updated: 2025-12-15
A Phase 1/2 First in Human Study of the Menin-MLL (KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
RecruitingCTIS2023-510509-17-00
Kura Oncology Inc.Relapsed and/or refractory Acute Myeloid Leukemia
Start: 2020-06-17Target: 145Updated: 2026-01-16
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
RecruitingNCT06655246
Kura Oncology, Inc.Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Cell Tumors, Gastrointestinal Stromal Neoplasm +2
Start: 2025-03-27End: 2028-12-01Target: 157Updated: 2026-02-05
A Phase 1 Trial of the Menin Inhibitor Ziftomenib in Combination with Chemotherapy for Children with Relapsed/Refractory KMT2A-rearranged, NUP98-rearranged, or NPM1-mutant Acute Leukemia
RecruitingCTIS2023-505262-28-00
Prinses Maxima Centrum voor Kinderoncologie B.V.Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia
Start: 2025-03-24Target: 10Updated: 2024-12-02
Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia
RecruitingNCT06769490
M.D. Anderson Cancer CenterAcute Myeloid Leukemia
Start: 2025-07-10End: 2030-09-15Target: 44Updated: 2026-02-11
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
Not yet recruitingNCT07355335
Massachusetts General HospitalKMT2A-rearranged, NPM1-mutant Refractory or Relapsed AML
Start: 2026-07-09End: 2028-01-01Target: 24Updated: 2026-01-22
Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia
Not yet recruitingNCT07411586
M.D. Anderson Cancer CenterAcute Myeloid Leukemia
Start: 2026-08-31End: 2029-01-14Target: 20Updated: 2026-02-17

Phase 2

Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy
Not yet recruitingNCT06930352
Uma BorateAcute Myeloid Leukemia
Start: 2026-04-10End: 2027-12-31Target: 70Updated: 2026-03-13

Phase 3

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
RecruitingNCT07007312
Kura Oncology, Inc.Acute Myeloid Leukemia (AML)
Start: 2025-09-26End: 2031-11-01Target: 1300Updated: 2026-03-13
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
Not yet recruitingCTIS2025-521314-25-00
Kura Oncology Inc.NPM1-m and KMT2A-r Acute Myeloid Leukemia
Target: 280Updated: 2026-02-23

Unknown Phase

Expanded Access to Ziftomenib
NCT05738538
Kura Oncology, Inc.Acute Lymphoblastic Leukemia, With Appropriate Mutations, Acute Myeloid Leukemia, With NPM1 Mutations
Updated: 2025-06-04

Related Papers

Phase l dose escalation and expansion of ziftomenib in combination with quizartinib in AML
Blood2025-11-031 citations
Ziftomenib in combination with venetoclax and azacitidine in newly diagnosed NPM1-m acute myeloid leukemia: Phase 1b results from KOMET-007
Blood2025-11-031 citations
Ziftomenib in combination with venetoclax and azacitidine in relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia: Updated phase 1a/b safety and clinical activity results from KOMET-007
Blood2025-11-031 citations
Trial in progress: A phase II study of ziftomenib monotherapy in unfit patients with newly diagnosed Acute Myeloid Leukemia with NPM1 mutation or KMT2A rearrangement
Blood2025-11-031 citations
Ziftomenib in relapsed/refractory (R/R) <i>NPM1</i> -mutant acute myeloid leukemia (AML): Phase 1b/2 clinical activity and safety results from the pivotal KOMET-001 study.
Journal of Clinical Oncology2025-05-284 citations
Phase 1a/1b study of the safety, pharmacokinetics, and antitumor activity of ziftomenib in combination with imatinib in patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure.
Journal of Clinical Oncology2025-05-28
Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed <i>NPM1-</i>m or <i>KMT2A</i>-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Blood2024-11-0521 citations
Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory <i>NPM1</i>-m or <i>KMT2A</i>-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Blood2024-11-0516 citations
APAL2020K/ITCC-101: A Phase I Trial of the Menin Inhibitor Ziftomenib in Combination with Chemotherapy in Children with Relapsed/Refractory <i>KMT2A-</i>rearranged<i>, NUP98-</i>rearranged<i>, or NPM1-</i>mutant Acute Leukemias
Blood2024-11-052 citations
A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine (ZiVA) in Pediatric Relapsed and Refractory Acute Leukemias
Blood2024-11-052 citations
Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial.
2024-10-0151 citations
Outcome of Infants Treated on Total Therapy for Infants with Acute Lymphoblastic Leukemia I: Results from a Non-Randomized Multi-Center Study
Blood2023-11-026 citations
P504: UPDATED DATA FOR ZIFTOMENIB IN PATIENTS WITH NPM1-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA
HemaSphere2023-08-0114 citations
Phase 1 study of ziftomenib (KO-539) in combination with venetoclax or venetoclax/azacitidine or standard induction cytarabine/daunorubicin (7+3) chemotherapy for the treatment of patients with acute myeloid leukemia.
Journal of Clinical Oncology2023-06-016 citations
Abstract 3457: Characterization of acquired resistance mutations to menin inhibitors
Cancer Research2023-04-049 citations
Clinical-Stage Menin Inhibitor KO-539 Is Synergistically Active with Multiple Classes of Targeted Agents in KMT2A-r and NPM1-Mutant AML Models
Blood2021-11-058 citations
Preliminary Data on a Phase 1/2A First in Human Study of the Menin-KMT2A (MLL) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Blood2020-11-0465 citations
STEM-29. THE HISTONE VARIANT macroH2A2 ORCHESTRATES AN ACTIONABLE CHROMATIN PROGRAM OF STEMNESS IN GLIOBLASTOMA
Neuro-Oncology2020-11-01