drugset / Trial / NCT04365179
Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
Phase 1
Recruiting
18 enrolled
Immune System Key Ltd
University of Miami Sylvester Comprehensive Cancer Center · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-06-18
- Primary completion
- 2025-06-30
- Completion
- 2025-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nerofe | Peptide | 6 mg/m2 | Intravenous |
| Subject | Nerofe | Peptide | 12 mg/m2 | Intravenous |
| Subject | Nerofe | Peptide | 24 mg/m2 | Intravenous |
| Subject | Nerofe | Peptide | 48 mg/m2 | Intravenous |
| Subject | Nerofe | Peptide | 96 mg/m2 | Intravenous |
| Subject | Nerofe | Peptide | 150 mg/m2 | Intravenous |