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Study identifier: NCT04365179 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML

Condition: Advanced MDS · AML  ·  Sponsor: Immune System Key Ltd

PhasePhase 1
Planned participants18
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined using the body surface area (BSA) measured on Day 1 of each cycle.

This description comes directly from the study's public registry record.

Talk to the study team

Justin Watts, MD  ·  305-243-3084  ·  jxw401@miami.edu

Amber Thomassen, APRN-BC  ·  305-243-7042  ·  axt283@miami.edu

Always discuss trial participation with your own doctor first.

Locations (1)

University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer CenterMiami, Florida, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04365179