A Phase 1 interventional study of OPN-6602 and Dexamethasone in Relapsed Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Opna Bio LLC. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Opna Bio LLC · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: OPN-6602
Drug: OPN-6602 · Drug: Dexamethasone
Drug: OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
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
Plan to share: No
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Opna Bio LLC