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NCT04365179 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of AML and Advanced MDS, sponsored by Immune System Key.

Recruiting
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT04365179: Recruiting Phase 1 study of AML and Advanced MDS, sponsored by Immune System Key.

NCT04365179 is a Phase 1 study of AML and Advanced MDS that is actively recruiting participants, run by Immune System Key. The registered enrollment target is 18 participants, below the 133-participant average among 29 other AML trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04365179, a Phase 1 study of AML and Advanced MDS, is actively recruiting participants, sponsored by Immune System Key.

RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

AML Advanced MDS

Interventions

  • DRUG Nerofe

Study Locations (1)

Florida

  • University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center - Miami

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2020-06-18
Est. Completion 2025-08-30
Phase Phase 1
Immune System Key

1 total trials

What NCT04365179 shows while recruiting

NCT04365179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 29 other AML trials with a reported enrollment target (86% lower).

The record links to 2 conditions, with AML appearing as the primary indexed condition, and to 1 intervention - of which Nerofe is the first listed.

NCT04365179 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT04365179 about?

NCT04365179 is a clinical study titled "Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML". 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 us...

What is the current status of trial NCT04365179?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-06-18. Estimated completion is 2025-08-30.

What conditions does trial NCT04365179 study?

This clinical trial studies the following conditions: AML, Advanced MDS.

What interventions are being tested in trial NCT04365179?

The interventions under investigation include: Nerofe (DRUG).

Who is sponsoring clinical trial NCT04365179?

This trial is sponsored by Immune System Key, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04365179 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for AML

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04365179's enrollment target sits among peer trials

18 25th of 29 higher than 4 of 29 other AML trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other AML trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04365179

Source: ClinicalTrials.gov NCT04365179, the US trial registry maintained by the National Library of Medicine. NCT04365179 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.