Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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
1 other identifier
interventional
130
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2024
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
August 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
CompletedMay 19, 2026
May 1, 2026
1.9 years
May 23, 2024
May 15, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number and type of dose-limiting toxicities (DLTs)
Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)
Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities
Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Through up to approximately 30 days following last dose of OPN-6602
Study Arms (3)
Dose escalation monotherapy
EXPERIMENTALDose escalation in combo with dexamethasone
EXPERIMENTALDose expansion
EXPERIMENTALInterventions
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Opna Bio LLClead
Study Sites (12)
Banner MD Anderson
Gilbert, Arizona, 85234, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698, United States
Stanford Cancer Institute
Stanford, California, 94305, United States
Emory Winchip Cancer Center
Atlanta, Georgia, 30322, United States
University of Kansas Clinical Research Center
Westwood, Kansas, 66205, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
START Midwest
Grand Rapids, Michigan, 49546, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina Hospitals at Hillsborough
Chapel Hill, North Carolina, 27599, United States
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, 84112, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2024
First Posted
May 30, 2024
Study Start
August 22, 2024
Primary Completion
July 1, 2026
Study Completion
July 1, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share