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
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.
Arms & interventions
- DrugOPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
- DrugDexamethasone
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Outcome measures
Primary
Number and type of dose-limiting toxicities (DLTs)
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities
Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Eligibility criteria
Study locations (12)
Banner MD Anderson
Gilbert, Arizona, 85234
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
Stanford Cancer Institute
Stanford, California, 94305
Emory Winchip Cancer Center
Atlanta, Georgia, 30322
University of Kansas Clinical Research Center
Westwood, Kansas, 66205
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
START Midwest
Grand Rapids, Michigan, 49546
University of Rochester Medical Center
Rochester, New York, 14642
University of North Carolina Hospitals at Hillsborough
Chapel Hill, North Carolina, 27599
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, 84112
Fred Hutchinson Cancer Center
Seattle, Washington, 98109