NCT06502145

Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome (MDS).

Detailed description

This is a single-arm, open-label phase 1 study designed to evaluate the safety of iadademstat with azacitidine therapy. The trial will follow a 3+3 phase 1 dose-escalation design. First, three participants are given a low dose of the experimental treatment and monitored for pre-specified toxicity events. If 0 participants experience one of these toxicity events, then the next group of three participants is enrolled at a higher dose. If two or three participants experience toxicity, then the next group of three participants is enrolled at a lower dose (or the study ends). If one participant experiences toxicity, another group of three participants is enrolled at the same dose (hence the name, 3+3): if one or more of those participants experience toxicity, then the dose is lowered for the next group of the study ends. Otherwise, if 0 of the additional participants experience toxicity, the next group is enrolled at a higher dose.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Azacitidine Level -1	Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
DRUG	Azacitidine Level 0	Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
DRUG	Azacitidine Level 1	Intravenous (IV) or subcutaneous (SC) 75 mg / m\^2 days 1-7 X 28 days.
DRUG	Iadademstat Level -1	75 µg by mouth (PO) 5 days on, 2 days off for 2 weeks every 28 days.
DRUG	Iadademstat Level 0	75 µg PO 5 days on, 2 days off for 3 weeks every 28 days.
DRUG	Iadademstat Level 1	100 µg PO 5 days on, 2 days off for 3 weeks every 28 days.

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-07-16
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study