Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
A Phase 1 Study of Menin-KMT2A Inhibitor Ziftomenib (KO-539) in Combination With Cereblon E3 Ligase Modulator Mezigdomide (CC-92480) in Adolescents and Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Sponsor: Massachusetts General Hospital + Kura Oncology, Inc., Bristol-Myers Squibb
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the start of treatment until participant withdrawal, death, or removal from study, whichever comes first, assessed up to 2 years after initial dose of study treatment.
Recommended phase 2 dose (RP2D) of mezigdomide in combination with ziftomenib.
Time frame: From start of treatment to end of 12 cycles (each cycle is 28 days).
Secondary Endpoints
Complete remission/complete remission with partial hematologic recovery (CR/CRh) and overall response rate (ORR)
2-year overall and relapse-free survival rates
Eligibility Criteria
Inclusion Criteria: * Age ≥16 years during dose escalation portion of study, patients must weigh ≥40 kg. * Age \>12 years during dose expansion portion of study, patients must weight ≥40 kg. * Diagnosis of AML per the WHO Classification of Hematolymphoid Tumors (5th Edition) with documented KMT2A rearrangement or NPM1 cytoplasmic-type (NPM1c) mutation. KMT2A-rearrangements must be confirmed by FISH or RNA-based fusion calling by a CLIA-certified laboratory. This study will only enroll KMT2A gene rearrangements in which there is a translocation between the N-terminal portion of KMT2A and a fusion partner, and will not include KMT2A partial tandem duplications (PTDs) or other structural alterations of KMT2A. NPM1c mutations must be confirmed by DNA sequencing in a CLIA-certified laboratory. Patients with myeloid sarcoma are eligible only if concurrent bone marrow involvement is present. Patients must have at least 5% bone marrow disease by morphology at the time of study entry. * Patien…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →