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Clinical trial · no report yet · Phase 1/Phase 2
NCT04067336
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
- NCT04067336 ↗
- Active, not recruiting
- Kura Oncology, Inc.
- Deep
We haven't built an HCP commentary report on NCT04067336 (ziftomenib, midazolam and 1 more in Advanced Malignant Neoplasm) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT04067336 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 18 | |
| YouTube | 15 | |
| Podcasts | 9 | |
| X videos | 2 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 1/Phase 2
- Status
- Active, not recruiting
- Conditions
- Advanced Malignant Neoplasm; Acute Myeloid Leukemia; Mixed Lineage Leukemia; Mixed Lineage Acute Leukemia; Acute Leukemia of Ambiguous Lineage; Mixed Phenotype Acute Leukemia; Acute Lymphoblastic Leukemia
- Interventions
- Ziftomenib; Midazolam; Itraconazole
- Arms
- Phase 1a - Dose Escalation · Experimental
- Phase 1b - Dose-Validation Expansion · Experimental
- Phase 2 · Experimental
- Sub-study 1 · Experimental
- Sub-study 2 · Experimental
- Sub-study 3 · Experimental
- Sub-study 4 · Experimental
- Enrollment
- 263 (estimated)
- Primary outcomes
- Phase 1a: Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
- Phase 1b: Number of patients who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Phase 1b: Minimum biologically effective dose
- Phase 1a, 1b, and 2: Evidence of anti-leukemia activity
- Sub-study 1: Time to observed maximum plasma concentration (Tmax) of ziftomenib and midazolam
- Sub-study 1: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and midazolam
- Sub-study 1: Maximum observed plasma concentration (Cmax) of ziftomenib and midazolam
- Sub-study 2: Time to observed maximum plasma concentration (Tmax) of ziftomenib and itraconazole
- Sub-study 2: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib and itraconazole
- Sub-study 2: Maximum observed plasma concentration (Cmax) of ziftomenib and itraconazole
- Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
- Sub-study 3: Minimum biologically effective dose (MBED) and/or the recommended Phase 2 dose (RP2D)
- Sub-study 3: Change in Eastern Cooperative Oncology Group (ECOG) status
- Sub-study 3: Time to observed maximum plasma concentration (Tmax) of ziftomenib
- Sub-study 3: Area under the plasma concentration-time curve from time 0 to time t (AUC0-t) of ziftomenib
- Sub-study 3: Maximum observed plasma concentration (Cmax) of ziftomenib
- Sub-study 4: Complete remission (CR) and complete remission with partial hematologic recovery (CRh)
- Sponsor
- Kura Oncology, Inc.
- Start
- Sep 12, 2019
- Primary completion
- Oct 16, 2028 (estimated)
- Results posted
- No
- Registry record
- NCT04067336 · updated May 13, 2026
Publications
linked from the registry- Wang ES, Montesinos P, Foran J, Erba H, Rodriguez-Arboli E, Fedorov K, Heiblig M, Heidel FH, Altman JK, Baer MR, Ades L, Pettit K, Peterlin P, Papayannidis C, Berthon C, Walter RB, Shah MV, Balasubramanian S, Khawandanah M, Salamero Garcia O, Bergeron J, Madanat YF, Roboz GJ, Ulrickson M, Redner RL, McCloskey J, Pigneux A, de la Fuente Burguera A, Mitra A, Soifer HS, Tabachri M, Zhang Z, Riches M, Corum D, Leoni M, Issa GC, Fathi AT; KOMET-001. Ziftomenib in Relapsed or Refractory NPM1-Mutated AML. J Clin Oncol. 2025 Nov;43(31):3381-3390. doi: 10.1200/JCO-25-01694. Epub 2025 Sep 25. PubMed 40997296
- Wang ES, Issa GC, Erba HP, Altman JK, Montesinos P, DeBotton S, Walter RB, Pettit K, Savona MR, Shah MV, Kremyanskaya M, Baer MR, Foran JM, Schiller G, Ades L, Heiblig M, Berthon C, Peterlin P, Rodriguez-Arboli E, Salamero O, Patnaik MM, Papayannidis C, Grembecka J, Cierpicki T, Clegg B, Ray J, Linhares BM, Nie K, Mitra A, Ahsan JM, Tabachri M, Soifer HS, Corum D, Leoni M, Dale S, Fathi AT. Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial. Lancet Oncol. 2024 Oct;25(10):1310-1324. doi: 10.1016/S1470-2045(24)00386-3. PubMed 39362248
- Sasca D, Guezguez B, Kuhn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673. PubMed 34267079
- Jimenez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19. PubMed 33741715