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

Opna Bio LLC

Status and phase: Enrolling; Phase 1

Conditions: Refractory Multiple Myeloma; Relapsed Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: OPN-6602

Study type: Interventional

Funder types: Industry

Identifiers

NCT06433947

OPN6602-C01

Details and patient eligibility

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Dose escalation monotherapy

Experimental group

Treatment:

Drug: OPN-6602

Dose escalation in combo with dexamethasone

Experimental group

Treatment:

Drug: OPN-6602

Drug: Dexamethasone

Dose expansion

Experimental group

Treatment:

Drug: OPN-6602