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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Opna Bio LLC · Participants: 130 · Started: Aug 22, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06433947

Locations in the U.S.

ArizonaBanner MD Anderson, Gilbert
CaliforniaUC San Diego Moores Cancer Center, La Jolla
Stanford Cancer Institute, Stanford
GeorgiaEmory Winchip Cancer Center, Atlanta
KansasUniversity of Kansas Clinical Research Center, Westwood
MassachusettsDana Farber Cancer Institute, Boston
MichiganKarmanos Cancer Institute, Detroit
START Midwest, Grand Rapids
New YorkUniversity of Rochester Medical Center, Rochester
North CarolinaUniversity of North Carolina Hospitals at Hillsborough, Chapel Hill
UtahHuntsman Cancer Center Institute University of Utah, Salt Lake City
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.