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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.