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RecruitingInterventionalPhase 1

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

NCT ID: NCT06433947Sponsor: Opna Bio LLCLast updated: 2026-05-19

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

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (12)

Banner MD Anderson

Gilbert, Arizona, 85234

Recruiting

UC San Diego Moores Cancer Center

La Jolla, California, 92093-0698

Recruiting
Rebecca Jimenez · Contact

Stanford Cancer Institute

Stanford, California, 94305

Recruiting
Caitlyn Minas · Contact

Emory Winchip Cancer Center

Atlanta, Georgia, 30322

Recruiting
Megan Marshall · Contact

University of Kansas Clinical Research Center

Westwood, Kansas, 66205

Recruiting
Nurse Navigation · Contact

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Kate Staub · Contact

START Midwest

Grand Rapids, Michigan, 49546

Recruiting

University of Rochester Medical Center

Rochester, New York, 14642

Recruiting

University of North Carolina Hospitals at Hillsborough

Chapel Hill, North Carolina, 27599

Recruiting
Brice Messenger, CCRP · Contact

Huntsman Cancer Center Institute University of Utah

Salt Lake City, Utah, 84112

Recruiting
Collind Boyington · Contact

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Danai Dima · Contact
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma | Cancerify