NCT05027594

Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma

A Phase I Dose Escalation Study of NMS-03597812, a PERK Inhibitor, in Adult Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Nerviano Medical Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, first-in-human (FIH), open-label, non-randomized, multi-center study to explore the safety, tolerability, pharmacokinetics and preliminary antitumor activity of NMS-03597812 in adult patients with RRMM who have exhausted standard treatment options that are expected to provide meaningful clinical benefit or for whom standard therapy is considered unsuitable.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	NMS-03597812	All patients will receive NMS-03597812 administered orally once daily on Days 1-21 in repeated 4-week cycles.
DRUG	NMS-03597812 + dexamethasone	All patients will receive NMS-03597812 administered orally once daily on Days 1-21 and Dexamethasone administered orally once a week on Days 1, 8, 15 and 22 in repeated 4-week cycles.

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-08-08
• Completion: 2024-01-08
• First posted: 2021-08-30
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study