NCT06769490

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Phase 1 Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r \~ 40-45%).

Detailed description

Primary Objective: Cohort 1A: To determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with quizartinib and assess the safety and the maximum tolerated dose (MTD). Secondary Objectives: To assess the preliminary efficacy of the combination of quizartinib and ziftomenib by FLT3 mutational status. To assess overall survival (OS), relapse-free survival (RFS), event-free survival (EFS) and duration of response (DOR). To characterize the pharmacokinetic profile of ziftomenib and quizartinib when used in combination. To assess minimal residual disease negativity by flow cytometry.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ziftomenib	Participants will receive treatment in tablet form
DRUG	Quizartinib	Participants will receive treatment in tablet form

Timeline

• Start date: 2025-07-10
• Primary completion: 2028-09-15
• Completion: 2030-09-15
• First posted: 2025-01-10
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study