Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
An Open-Label Phase 1b Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Immune System Key Ltd
18 participants
Jun 18, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
Locations(1)
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NCT04365179