Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06433947

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

Led by Opna Bio LLC · Updated on 2026-04-13

130

Participants Needed

11

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of multiple myeloma
  • Relapsed or refractory to 3 or more prior treatments including immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody
  • Not a candidate for or intolerant to established therapies known to provide clinical benefit
  • Adequate blood, kidney, liver, and heart function
Not Eligible

You will not qualify if you...

  • Diagnosis of monoclonal gammopathy of undetermined significance, smoldering myeloma, Waldenstr48's macroglobulinemia, or IgM myeloma
  • Active plasma cell leukemia
  • POEMS syndrome
  • History of Stevens Johnson syndrome
  • Localized radiation therapy within 2 weeks before first dose
  • Autologous stem cell or bone marrow transplant within 90 days before first dose
  • Allogeneic stem cell or solid organ transplant within 12 months before first dose
  • Receiving immunosuppressive medication for active graft versus host disease
  • Chemotherapy, targeted cancer therapy, or radiation therapy within 2 weeks before first dose
  • Use of high-dose corticosteroids except for chronic steroids for non-myeloma disorders
  • Multiple myeloma involvement in the central nervous system
  • Active second cancer except treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, or certain low-risk prostate cancers
  • Systemic infection requiring intravenous treatment
  • Poorly controlled Type 2 diabetes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Banner MD Anderson

Gilbert, Arizona, United States, 85234

Actively Recruiting

2

Stanford Cancer Institute

Stanford, California, United States, 94305

Actively Recruiting

3

Emory Winchip Cancer Center

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

University of Kansas Clinical Research Center

Westwood, Kansas, United States, 66205

Actively Recruiting

5

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

6

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

7

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

8

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

9

University of North Carolina Hospitals at Hillsborough

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

10

Huntsman Cancer Center Institute University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

11

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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