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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose escalation monotherapy
  • Drug: OPN-6602
    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Experimental
Dose escalation in combo with dexamethasone
  • Drug: OPN-6602
    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
  • Drug: Dexamethasone
    Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Experimental
Dose expansion
  • Drug: OPN-6602
    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily

Recruiting Locations

University of Kansas Clinical Research Center
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
Opna Bio LLC

Study Contact

Kerry Inokuchi
650-204-4065
kinokuchi@opnabio.com