Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Relapsed Multiple MyelomaRefractory Multiple Myeloma
- Interventions
- Registration Number
- NCT06433947
- Lead Sponsor
- Opna Bio LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose escalation monotherapy OPN-6602 - Dose expansion OPN-6602 - Dose escalation in combo with dexamethasone OPN-6602 - Dose escalation in combo with dexamethasone Dexamethasone -
- Primary Outcome Measures
Name Time Method Number and type of dose-limiting toxicities (DLTs) Through up to approximately 30 days following last dose of OPN-6602 Number and type of treatment-emergent adverse events (TEAEs) Through up to approximately 30 days following last dose of OPN-6602 Number of Participants With Clinical Laboratory Test Abnormalities Through up to approximately 30 days following last dose of OPN-6602 Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Banner MD Anderson
🇺🇸Gilbert, Arizona, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
Emory Winchip Cancer Center
🇺🇸Atlanta, Georgia, United States
University of Kansas Clinical Research Center
🇺🇸Westwood, Kansas, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Huntsman Cancer Center Institute University of Utah
🇺🇸Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States