[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Opna Bio LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100549432","phase-1-study-to-assess-safety-and-tolerability-of-opn-6602-in-subjects-with-relapsed-andor-refractory-multiple-myeloma-100549432",false,"NCT06433947","Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and\u002For Refractory Multiple Myeloma","A Phase 1b, Dose Escalation\u002FDose 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\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Confirmed diagnosis of multiple myeloma (MM)\n* 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\n* Adequate hematologic, renal, liver, cardiac function\n\nExclusion Criteria:\n\n* Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma\n* Active plasma cell leukemia\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)\n* Prior Stevens Johnson syndrome\n* Localized radiation therapy to disease site(s) within 2 weeks of the first dose\n* Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \\\u003C90 days of the first dose of study drug\n* 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.\n* Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug\n* Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)\n* Known central nervous system involvement by multiple myeloma\n* 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 \\\u003C7 and a PSA level \\\u003C10 ng\u002FmL; any other cancer from which the subject has been disease-free for ≥3 years\n* Ongoing systemic infection requiring parenteral treatment\n* Poorly controlled Type 2 diabetes","ALL","18 Years",{"count":19,"type":20},130,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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\u002For refractory MM.",[26,27],"Relapsed Multiple Myeloma","Refractory Multiple Myeloma","RECRUITING","2026-05-15",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":32},"2024-08-22",{"date":36,"type":20},"2026-07",{"name":38,"class":39},"Opna Bio LLC","INDUSTRY",12,""]