Back to Trials
NCT06433947PHASE1Recruiting

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

Opna Bio LLC

Start Date

8/22/2024

Completion Date

7/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

OPN-6602

DRUG

Dexamethasone

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Relapsed Multiple MyelomaRefractory Multiple Myeloma

Locations

Banner MD Anderson

Gilbert, Arizona 85234

United States

UC San Diego Moores Cancer Center

La Jolla, California 92093-0698

United States

Stanford Cancer Institute

Stanford, California 94305

United States

Emory Winchip Cancer Center

Atlanta, Georgia 30322

United States

University of Kansas Clinical Research Center

Westwood, Kansas 66205

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

START Midwest

Grand Rapids, Michigan 49546

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

University of North Carolina Hospitals at Hillsborough

Chapel Hill, North Carolina 27599

United States

Huntsman Cancer Center Institute University of Utah

Salt Lake City, Utah 84112

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States