Recruiting
Phase 1

OPN-6602

Sponsor:

Opna Bio LLC

Code:

NCT06433947

Conditions

Relapsed Multiple Myeloma

Refractory Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OPN-6602

Dexamethasone

Study Details

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.

Conditions

Relapsed Multiple Myeloma

Refractory Multiple Myeloma

Study ID

NCT06433947

Start date

Aug 22, 2024

Status verified date

May, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation monotherapy

experimental: Dose escalation in combo with dexamethasone

experimental: Dose expansion

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Banner MD Anderson

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Brett Post

480-256-3116brett.post@bannerhealth.com

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093-0698

Contacts

Rebecca Jimenez

858-822-5377rejimenez@health.ucsd.edu

Stanford Cancer Institute

Recruiting

Stanford, California, United States, 94305

Contacts

Caitlyn Minas

650-723-0646cminas@stanford.edu

Emory Winchip Cancer Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Megan Marshall

404-778-5204megan.marshall@emory.edu

University of Kansas Clinical Research Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Nurse Navigation

913-945-7552CTNurseNav@kumc.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Yuxin Liu

877-422-3324yuxin_liu@dfci.harvard.edu

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Kate Staub

313-576-8736staubk@karmanos.org

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Julie Burns

616-954-5559Julie.burns@startresearch.com

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Liu

585-275-5823wcicto@urmc.rochester.edu

University of North Carolina Hospitals at Hillsborough

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Brice Messenger, CCRP

919-966-4432brice_messenger@med.unc.edu

Huntsman Cancer Center Institute University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Collind Boyington

801-587-4779collind.boyington@hci.utah.edu

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Danai Dima

855-557-0555ddima@fredhutch.org

More Information

Sponsor

Opna Bio LLC

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Opna Bio LLC on 2026-05-19.