Go back to trials list
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
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.
Trial Eligibility
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 * Ongoing systemic infection requiring parenteral treatment * Poorly controlled Type 2 diabetes
Study Info
Organization
Opna Bio LLC
Primary Outcome
Number and type of dose-limiting toxicities (DLTs)
Interventions
Locations Recruiting
Dana Farber Cancer Institute
United States, Massachusetts, Boston
START Midwest
United States, Michigan, Grand Rapids
Interested in joining this trial?
Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.
![newsletter icon](https://static.healthtree.org/icons/newsletter-icon.png)
Get the latest thought leadership on your Multiple Myeloma delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.
Thanks to our HealthTree Community for Multiple Myeloma Sponsors:
![Johnson and Johnson](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2FJohnson%20&%20Johnson%20Logo_64b18f59-85c9-4c20-a5ff-3842e69d8066.jpg?alt=media)
![Sanofi](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2FSanofi%20updated%202023_d25a8d12-4f09-410c-9eb1-1e725b0b7c3e.jpg?alt=media)
![Pfizer](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2FPfizer%20Logo%202024_50ae4587-5fdc-48e2-9a52-21651c643494.png?alt=media)
![Genentech](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/admin%2Fpublic%2Fshared%2FGenentech_Logo-700x182_e3c64168-dcf4-4540-9e9d-26500b26920a.png?alt=media)
![Regeneron](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2FRegeneron_dec43aa4-fe53-4d5a-9b7f-4170101b47f9.webp?alt=media)
![Adaptive](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2FAdaptive%20Logo%204.2023_e0d11d37-8b31-4c88-a0fc-4d07efc9b16b.png?alt=media)