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

Description

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.

Conditions

Relapsed Multiple Myeloma, Refractory Multiple Myeloma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Relapsed Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson, Gilbert, Arizona, United States, 85234

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Grand Rapids

START Midwest, Grand Rapids, Michigan, United States, 49546

Seattle

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 screening; 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Opna Bio LLC,

Study Record Dates

2026-07