A Phase Ib, 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

Study Identifier:
OPN6602-C01
CT.gov Identifier:
NCT06433947
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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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.

To evaluate the safety, tolerability, PK, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM

This study consists of 3 parts: Part 1a OPN-6602 monotherapy dose escalation (Part 1a), Part 1b OPN-6602 combination with dexamethasone dose escalation (Part 1b), and Part 2 dose expansion of the preferred regimen (Part 2) to select and optimize the dose with 1:1 randomization of at least 2 potential dose levels of 20 subjects at each dose level (ie, the provisional recommended Phase 2 dose [RP2D] identified in Part 1a or Part 1b and 1 additional dose level). Either OPN-6602 monotherapy or OPN-6602 in combination with dexamethasone will be selected for Part 2. Up to 130 total evaluable subjects will be enrolled across dose escalation and dose expansion.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Multiple Myeloma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose escalation monotherapy
    • Read More
  • Drug: Experimental: Dose escalation in combo with dexamethasone
  • Drug: Drug: Dexamethasone
  • Drug: ASH 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 myelomaActive plasma cell leukemiaPolyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)Prior Stevens Johnson syndromeLocalized radiation therapy to disease site(s) within 2 weeks of the first dosePrior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the first dose of study drugPrior 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 drugConcomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)Known central nervous system involvement by multiple myelomaActive 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 yearsOngoing systemic infection requiring parenteral treatmentPoorly controlled Type 2 diabetes

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Andrew Sochacki
    Status
    Recruiting
    Condition(s) Treated at Site
    Multiple Myeloma