Recruiting NCT06433947
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OPN-6602, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Relapsed Multiple Myeloma, Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- 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
Primary outcome measures
- Number and type of dose-limiting toxicities (DLTs) [Time frame: Through up to approximately 30 days following last dose of OPN-6602]
- Number and type of treatment-emergent adverse events (TEAEs) [Time frame: Through up to approximately 30 days following last dose of OPN-6602]
- Number of Participants With Clinical Laboratory Test Abnormalities [Time frame: Through up to approximately 30 days following last dose of OPN-6602]
Eligibility criteria
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 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 12 centers
- Banner MD Anderson — Gilbert
- UC San Diego Moores Cancer Center — La Jolla
- Stanford Cancer Institute — Stanford
- Emory Winchip Cancer Center — Atlanta
- University of Kansas Clinical Research Center — Westwood
- Dana Farber Cancer Institute — Boston
- Karmanos Cancer Institute — Detroit
- START Midwest — Grand Rapids
- … and 4 more centers
Identifiers
NCT: NCT06433947 · OPN6602-C01