Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
NCT ID: NCT06433947
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
130 participants
INTERVENTIONAL
2024-08-22
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation monotherapy
OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Dose escalation in combo with dexamethasone
OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Dexamethasone
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Dose expansion
OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Interventions
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OPN-6602
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Dexamethasone
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Opna Bio LLC
INDUSTRY
Responsible Party
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Locations
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Banner MD Anderson
Gilbert, Arizona, United States
Stanford Cancer Institute
Stanford, California, United States
Emory Winchip Cancer Center
Atlanta, Georgia, United States
University of Kansas Clinical Research Center
Westwood, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Facility Contacts
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Other Identifiers
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OPN6602-C01
Identifier Type: -
Identifier Source: org_study_id
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