Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Number and type of dose-limiting toxicities (DLTs) — Through up to approximately 30 days following last dose of OPN-6602
- Number and type of treatment-emergent adverse events (TEAEs) — Through up to approximately 30 days following last dose of OPN-6602
- Number of Participants With Clinical Laboratory Test Abnormalities — Through up to approximately 30 days following last dose of OPN-6602
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.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Stanford Cancer Institute | Stanford | California | Recruiting |
| Emory Winchip Cancer Center | Atlanta | Georgia | Recruiting |
| University of Kansas Clinical Research Center | Westwood | Kansas | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| University of Rochester Medical Center | Rochester | New York | Recruiting |
| University of North Carolina Hospitals at Hillsborough | Chapel Hill | North Carolina | Recruiting |
| Huntsman Cancer Center Institute University of Utah | Salt Lake City | Utah | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06433947 on ClinicalTrials.gov ↗ ← All trials in the USA