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Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Sponsor: Opna Bio LLC
Summary
Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.
Official title: A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2024-08-22
Completion Date
2026-07
Last Updated
2025-08-19
Healthy Volunteers
No
Interventions
OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Dexamethasone
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Locations (10)
Banner MD Anderson
Gilbert, Arizona, United States
Stanford Cancer Institute
Stanford, California, United States
Emory Winchip Cancer Center
Atlanta, Georgia, United States
University of Kansas Clinical Research Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States