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

Last updated: May 11, 2025
Sponsor: Opna Bio LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

OPN-6602

Dexamethasone

Clinical Study ID

NCT06433947
OPN6602-C01
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma (MM)

  • Relapsed or refractory to 3 or more different prior lines of therapy for MM thatincluded immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody andnot a candidate for or intolerant to established therapy known to provide clinicalbenefit

  • Adequate hematologic, renal, liver, cardiac function

Exclusion

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 marrowtransplantation within <90 days of the first dose of study drug

  • Prior allogeneic stem cell transplantation or solid organ transplantation within 12months of screening; subjects receiving immunosuppressive medication for activegraft vs host disease will be excluded.

  • Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior tofirst dose of study drug

  • Concomitant high-dose corticosteroids (except subjects on chronic steroids given fordisorders other than myeloma)

  • Known central nervous system involvement by multiple myeloma

  • Active known second malignancy with exception of adequately treated basal cellcarcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer;adequately treated Stage 1 cancer from which the subject is currently in remissionand has been in remission for ≥2 years; low-risk prostate cancer with a Gleasonscore <7 and a PSA level <10 ng/mL; any other cancer from which the subject has beendisease-free for ≥3 years

  • Ongoing systemic infection requiring parenteral treatment

  • Poorly controlled Type 2 diabetes

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: OPN-6602
Phase: 1
Study Start date:
August 22, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Banner MD Anderson

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • Stanford Cancer Institute

    Stanford, California 94305
    United States

    Active - Recruiting

  • Emory Winchip Cancer Center

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Kansas Clinical Research Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Huntsman Cancer Center Institute University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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