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Clinical trial · no report yet · Phase 1

NCT05735184

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

  • NCT05735184 ↗
  • Recruiting
  • Kura Oncology, Inc.
  • 71 commentary sources found
  • Deep

We haven't built a report for this trial 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.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads27
YouTube25
Podcasts15
X videos4

The trial

ClinicalTrials.gov
Official title
Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia
Phase
Phase 1
Status
Recruiting
Conditions
Acute Myeloid Leukemia; Mixed Lineage Leukemia Gene Mutation; Refractory AML; AML With Mutated NPM1; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, in Relapse; NPM1 Mutation; KMT2Ar; Myeloid Sarcoma; Nucleophosmin 1-mutated Acute Myeloid Leukemia
Interventions
Ziftomenib; Venetoclax; Azacitidine; Daunorubicin; Cytarabine; Quizartinib
Arms
  • Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1) · Experimental
  • Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R NPM1-m (A-1) · Experimental
  • Dose Escalation: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2) · Experimental
  • Dose Validation/Expansion: Ziftomenib with 7+3 in 1L NPM1-m/FLT3 wildtype (A-2) · Experimental
  • Dose Validation/Expansion: Ziftomenib with Venetoclax in R/R NPM1-m (A-3) · Experimental
  • Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in 1L NPM1-m (A-4) · Experimental
  • Dose Escalation: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1) · Experimental
  • Dose Validation/Expansion: Ziftomenib with Venetoclax and Azacitidine in R/R KMT2A-r (B-1) · Experimental
  • Dose Escalation: Ziftomenib with 7+3 in 1L KMT2A-r (B-2) · Experimental
  • Dose Validation/Expansion: Ziftomenib with 7+3 in 1L KMT2A-r (B-2) · Experimental
  • Dose Validation/Expansion: Ziftomenib with Venetoclax + Azacitidine in 1L KMT2A-r (B-3) · Experimental
  • Dose Escalation: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1) · Experimental
  • Dose Validation/Expansion: Ziftomenib with 7+3+quizartinib in 1L NPM1-m/FLT3-ITD+ AML patients (C-1) · Experimental
Enrollment
420 (estimated)
Primary outcomes
  • Rate of dose limiting toxicities (DLTs) per dose level (Part 1a only)
  • Descriptive statistics of adverse events
  • Complete remission (CR) rate
Sponsor
Kura Oncology, Inc.
Start
Jul 18, 2023
Primary completion
Apr 2030 (estimated)
Results posted
No
Registry record
NCT05735184 · updated Mar 13, 2026

Publications

linked from the registry
  • Wang ES, Erba HP, Zeidan AM, Roboz GJ, Altman JK, Advani AS, Lin TL, Strickland SA, Juckett MB, Pratz KW, Mangan JK, McMahon CM, Alsfeld LC, Balasubramanian SK, Guru Murthy GS, Rotta M, Palmisiano N, McCloskey J, Saliba AN, Khawandanah M, Madanat YF, Naqvi K, Qasrawi AH, Schiller GJ, Badar T, Gojo I, Yaghmour G, Osman D, Zhang H, Tian Y, Soifer HS, Riches M, Corum D, Leoni M, Fathi AT, Issa GC. Ziftomenib with venetoclax and azacitidine in relapsed/refractory NPM1-mutated acute myeloid leukemia. Blood. 2026 Jun 2:blood.2026034043. doi: 10.1182/blood.2026034043. Online ahead of print. PubMed 42227701