Tests OPN-6602 safety in adults with relapsed or refractory multiple myeloma
Tests OPN-6602, alone or with dexamethasone, in adults with returning multiple myeloma.
Plain-language title generated from the registry record
Registry title: Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Key facts
- Where
- Atlanta, Boston, Chapel Hill, Detroit, Gilbert, Grand Rapids, La Jolla, Rochester, Salt Lake City, Seattle, Stanford, and Westwood, United StatesSee the 12 sites
- Phase
- Phase 1
Where in United States
- Emory Winchip Cancer CenterAtlanta, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- University of North Carolina Hospitals at HillsboroughChapel Hill, United StatesTaking people
- Karmanos Cancer InstituteDetroit, United StatesTaking people
- Banner MD AndersonGilbert, United StatesTaking people
- START | MidwestGrand Rapids, United StatesTaking people
- UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- Huntsman Cancer Center Institute University of UtahSalt Lake City, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Stanford Cancer InstituteStanford, United StatesTaking people
- University of Kansas Clinical Research CenterWestwood, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Opna Bio LLC
- Trial code
- NCT06433947
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior Stevens Johnson syndrome; 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); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome); Localized radiation therapy to disease site(s) within 2 weeks of the first dose; Ongoing systemic infection requiring parenteral treatment; Poorly controlled Type 2 diabetes; 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; Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma; Active plasma cell leukemia; Known central nervous system involvement by multiple myeloma.