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Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML

NCT07355335 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).

Conditions

  • KMT2A-rearranged
  • NPM1-mutant Refractory or Relapsed AML

Interventions

DRUG

Ziftomenib

Capsule taken orally once daily on days 1-28 of each 28-day cycle.

DRUG

Mezigdomide

Capsule taken orally once daily on days 1-21 or possibly days 1-14 of each 28-day cycle.

Sponsors & Collaborators

  • Kura Oncology, Inc.

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Amir Fathi, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2027-07-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355335 on ClinicalTrials.gov