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Official Title
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
Phase 1
Sponsor
Opna Bio LLC
Enrollment
130
Timeline
Aug 2024 → Jul 2026
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Confirmed diagnosis of multiple myeloma (MM)
- 2Relapsed 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
- 3Adequate hematologic, renal, liver, cardiac function
Exclusion Criteria
- 1Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
- 2Active plasma cell leukemia
- 3Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
- 4Prior Stevens Johnson syndrome
- 5Localized radiation therapy to disease site(s) within 2 weeks of the first dose
- 6Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug
- 7Prior 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.
- 8Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
- 9Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
- 10Known central nervous system involvement by multiple myeloma
- 11Active 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
- 12Ongoing systemic infection requiring parenteral treatment
- 13Poorly controlled Type 2 diabetes
Locations
10 sites participating in this study
Emory Winchip Cancer Center
Atlanta, Georgia 30322
Megan Marshall
Banner MD Anderson
Gilbert, Arizona 85234
Brett Post
Stanford Cancer Institute
Stanford, California 94305
Caitlyn Minas
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →