RecruitingPhase 1NCT06433947

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


Sponsor

Opna Bio LLC

Enrollment

130 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety and tolerability of a new drug called OPN-6602 in people with multiple myeloma (a type of blood cancer) whose disease has come back or stopped responding to multiple previous treatments. **You may be eligible if...** - You have a confirmed diagnosis of multiple myeloma - Your myeloma has relapsed (come back) or is refractory (not responding) after at least 3 different prior treatment regimens, which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody - You are no longer a candidate for or cannot tolerate other known effective treatments - Your blood counts, kidney, liver, and heart function are within acceptable ranges **You may NOT be eligible if...** - You have MGUS, smoldering myeloma, Waldenström's macroglobulinemia, IgM myeloma, plasma cell leukemia, or POEMS syndrome - You have a history of Stevens-Johnson syndrome (a severe skin reaction) - You received radiation or a stem cell transplant recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(11)

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

University of North Carolina Hospitals at Hillsborough

Chapel Hill, North Carolina, United States

Huntsman Cancer Center Institute University of Utah

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06433947


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