Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Recruiting now · Phase 1

Conditions studied: Relapsed Multiple Myeloma, Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06433947

Run by

Opna Bio LLC

People needed

130

Starts

2024-08-22

Expected to finish

2026-07-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner MD Anderson — Gilbert, Arizona, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• Emory Winchip Cancer Center — Atlanta, Georgia, United States (enrolling)
• University of Kansas Clinical Research Center — Westwood, Kansas, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• University of North Carolina Hospitals at Hillsborough — Chapel Hill, North Carolina, United States (enrolling)
• Huntsman Cancer Center Institute University of Utah — Salt Lake City, Utah, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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