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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma (MM)
* Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
* Adequate hematologic, renal, liver, cardiac function
Exclusion Criteria:
* Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
* Active plasma cell leukemia
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
* Prior Stevens Johnson syndrome
* Localized radiation therapy to disease site(s) within 2 weeks of the first dose
* Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug
* Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.
* Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
* Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
* Known central nervous system involvement by multiple myeloma
* Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years
* Ongoing systemic infection requiring parenteral treatment
* Poorly controlled Type 2 diabetes
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
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.
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