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

ConditionsRelapsed Multiple MyelomaRefractory 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • OPN-6602

    Drug

    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily

  • Dexamethasone

    Drug

    Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Dose escalation monotherapyExperimental treatment 1 intervention
Group B: Dose escalation in combo with dexamethasoneExperimental treatment 2 interventions
Group C: Dose expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number and type of dose-limiting toxicities (DLTs)

Time frame
Through up to approximately 30 days following last dose of OPN-6602
2

Number and type of treatment-emergent adverse events (TEAEs)

Time frame
Through up to approximately 30 days following last dose of OPN-6602
3

Number of Participants With Clinical Laboratory Test Abnormalities

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.

Time frame
Through up to approximately 30 days following last dose of OPN-6602

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Opna Bio LLC

Lead sponsor

Source ClinicalTrials.gov
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