> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-assess-safety-and-tolerability-of-opn-6602-in-dbffd2a4-80e8-489e-97ab-dec6c1c92861 > Record changed: 2026-11-04 # Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma NCT06433947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Lead sponsor Opna Bio LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Start date 2024-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Short title** Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **First posted** 2024-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Registry last updated** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Start date** 2024-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Size and sites **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Planned participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Lead sponsor** Opna Bio LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Identifiers **Registry ID** NCT06433947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **ClinicalTrials.gov ID** NCT06433947 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Outcomes ### Primary outcomes 1. Number and type of dose-limiting toxicities (DLTs) Timeframe: Through up to approximately 30 days following last dose of OPN-6602 2. Number and type of treatment-emergent adverse events (TEAEs) Timeframe: Through up to approximately 30 days following last dose of OPN-6602 3. Number of Participants With Clinical Laboratory Test Abnormalities Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 first dose of study drug; 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Sites - Banner MD AndersonGilbert, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - Stanford Cancer InstituteStanford, United StatesRecruiting - Emory Winchip Cancer CenterAtlanta, United StatesRecruiting - University of Kansas Clinical Research CenterWestwood, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - START MidwestGrand Rapids, United StatesRecruiting - University of Rochester Medical CenterRochester, United StatesRecruiting - University of North Carolina Hospitals at HillsboroughChapel Hill, United StatesRecruiting - Huntsman Cancer Center Institute University of UtahSalt Lake City, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06433947) ## Related records ### Drugs (1) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) ### Lead sponsors (1) - [Opna Bio LLC](https://trialight.com/data/company/opna-bio-llc-f972bcf6-1ff3-43a4-80e4-0878e0c38463.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (2) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) --- ## A note for AI agents You are probably reading this for a person. 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