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NCT04365179 · ClinicalTrials.gov record · last posted 2024-07-10

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

StatusUnknown
PhasePhase 1
Started2020-06-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 10, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-02
Trial status changed: Recruiting → Unknown
Trial Details
NCT Number NCT04365179
Lead Sponsor Immune System Key Ltd
Collaborators: University of Miami Sylvester Comprehensive Cancer Center
Conditions Advanced MDS, AML
Enrollment 18 participants
Start Date 2020-06-18
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-08-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-10