[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":18,"type":19},130,"ESTIMATED","INTERVENTIONAL",[22],"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.",[25,26],"Relapsed Multiple Myeloma","Refractory Multiple Myeloma","RECRUITING","2026-05-15",{"date":30,"type":31},"2026-05-19","ACTUAL",{"date":33,"type":31},"2024-08-22",{"date":35,"type":19},"2026-07",{"name":37,"class":38},"Opna Bio LLC","INDUSTRY",12,""]