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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Banner MD Anderson
Gilbert, Arizona, United States
RECRUITINGStanford Cancer Institute
Stanford, California, United States
RECRUITINGNumber 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
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Emory Winchip Cancer Center
Atlanta, Georgia, United States
RECRUITINGUniversity of Kansas Clinical Research Center
Westwood, Kansas, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGHuntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
RECRUITING