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Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Trial Status: active
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 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 screening; 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
