Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOpna Bio LLC
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OPN-6602
- Dexamethasone
Treatment groups
130 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov