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

Part of paid clinical trials in Miami, Florida.

Sponsor
Immune System Key Ltd
Study ID
NCT04365179
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • AML
  • Advanced MDS

Eligibility Criteria

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

Interventions

  • Nerofe — DRUG
    Up to 12 cycles of 28 days are planned. If patients are deriving benefit, treatment may continue past 12 cycles. Cycle 1: During Cycle 1, assigned NEROFE doses will be administered by intravenous (IV) infusion over 1 hour on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26. Cycles 2-12: Subsequent cycles will be administered as above, presuming that patients do not meet criteria for study withdrawal during cycle 1.

Study Details

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.

Key Dates

Start date
Jun 18, 2020
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NEROFE
    Dose Level - Nerofe Dose -1 - 6mg/m2 1. \- 12 mg/m2 2. \- 24 mg/m2 3. \- 48 mg/m2 4. \- 96 mg/m2 5. \- 150mg/m2

Primary Outcome Measure

Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients [ Time Frame: At Screening (Day 1), at cycle 3 (Day 1) at cycle 5 (Day 1), at cycle 7 (Day 1), at cycle 9 (Day 1) at cycle 11 (Day 1) and at End of Treatment Visit. Cycle length is 28 days. Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Justin M Watts, MD
[email protected]
305-243-3084
Amber Thomassen, RN
[email protected]
305 243 7042
Justin M Watts, MD (PRINCIPAL_INVESTIGATOR)
Namrata Chandhok, MD (SUB_INVESTIGATOR)
Terrance Bradley, MD (SUB_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center· Miami, FL

Related Studies