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RecruitingNCT06433947Updated May 19, 2026

Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma

A Phase 1 interventional study of OPN-6602 and Dexamethasone in Relapsed Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Opna Bio LLC. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Opna Bio LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Dose escalation monotherapy

    Drug: OPN-6602

  • Experimental
    Dose escalation in combo with dexamethasone

    Drug: OPN-6602 · Drug: Dexamethasone

  • Experimental
    Dose expansion

    Drug: OPN-6602

Interventions

  • DrugOPN-6602

    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily

  • DrugDexamethasone

    Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle

05

What researchers measure

Primary outcomes

  1. Number and type of dose-limiting toxicities (DLTs)

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

  2. Number and type of treatment-emergent adverse events (TEAEs)

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

  3. 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.

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

06

Study locations

12 of 12 sites recruiting
  • Banner MD Anderson
    Gilbert, Arizona 85234, United States
    Recruiting
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093-0698, United States
    Recruiting
  • Stanford Cancer Institute
    Stanford, California 94305, United States
    Recruiting
  • Emory Winchip Cancer Center
    Atlanta, Georgia 30322, United States
    Recruiting
  • University of Kansas Clinical Research Center
    Westwood, Kansas 66205, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Recruiting
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
    Recruiting
  • START Midwest
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
    Recruiting
  • University of North Carolina Hospitals at Hillsborough
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Huntsman Cancer Center Institute University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
  • Fred Hutchinson Cancer Center
    Seattle, Washington 98109, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06433947
Lead sponsor
Opna Bio LLC
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Aug 22, 2024
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 19, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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