Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT04365179 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Immune System Key

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04365179

The ClinicalTrials.gov registry entry for NCT04365179 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immune System Key, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04365179 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04365179?

The interventions under investigation include: Nerofe (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04365179?

This trial is sponsored by Immune System Key, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial