Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Relapsed/Refractory AML, ALL, or MPAL

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Meryx, Inc.
Study ID
NCT04872478
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRX-2843 — DRUG
    MRX-2843 capsules

Study Details

This is a Phase I, open-label, non-randomized, dose escalation study in adolescents and adults with relapsed/refractory acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia. Patients will receive continuous oral MRX-2843 in 28 day cycles at predefined dose cohorts.

Key Dates

Start date
Apr 1, 2022
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Level 1
    MRX-2843 capsules, QD - 28 day cycles
  • Experimental: Dose Escalation - Level 2
    MRX-2843 capsules, QD - 28 day cycles
  • Experimental: Dose Escalation - Level 3
    MRX-2843 capsules, QD - 28 day cycles
  • Experimental: Dose Escalation - Level 4
    MRX-2843 capsules, QD - 28 day cycles
  • Experimental: Dose Escalation - Level 5
    MRX-2843 capsules, QD - 28 day cycles
  • Experimental: Expansion Arm at RP2D
    MRX-2843 capsules, QD - 28 day cycles

Primary Outcome Measure

Percentage of subjects with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to the end of Cycle 1 (up to 28 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University - WINSHIP Cancer CenterAtlantaGeorgia30322
William Blum, MD
Emory University, Children's Healthcare of AtlantaAtlantaGeorgia30322
Melinda Pauly, MD
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Dr. Neerav Shukla
Neerav Shukla (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Emory University - WINSHIP Cancer Center· Atlanta, GAEmory University, Children's Healthcare of Atlanta· Atlanta, GAMemorial Sloan Kettering Cancer Center· New York, NY

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