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

Phase 1

Recruiting

• Conditions: Relapsed Multiple Myeloma; Refractory Multiple Myeloma
• Interventions: Drug: OPN-6602; Drug: Dexamethasone

• Registration Number: NCT06433947
• Lead Sponsor: Opna Bio LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-08-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-11
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 screening; 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation monotherapy	OPN-6602	-
Dose expansion	OPN-6602	-
Dose escalation in combo with dexamethasone	OPN-6602	-
Dose escalation in combo with dexamethasone	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Number and type of dose-limiting toxicities (DLTs)	Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)	Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities	Through up to approximately 30 days following last dose of OPN-6602	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.

Trial Locations

Locations (10)

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

Huntsman Cancer Center Institute University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States