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Clinical Trial 19378

Cancer Type:
Interventions:Not Applicable; SGN-CD48A

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Jason Brayer

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1 Study of SGN-CD48A in Patients with Relapsed or Refractory Multiple Myeloma

Summary

This study will test the safety and activity of SGN-CD48A given every 3 weeks to patients with multiple myeloma.

Objective

OBJECTIVES Primary Objective: Evaluate the safety and tolerability of SGN-CD48A in patients with RRMM. Identify the maximum tolerated dose (MTD) of SGN-CD48A in patients with RRMM. Secondary Objectives: Identify a recommended single-agent dose and schedule of SGN-CD48A. Assess PK of SGN-CD48A. Assess immunogenicity of SGN-CD48A. Assess antitumor activity of SGN-CD48A. Additional Objectives: Assess incidence and level of CD48 expression in RRMM and relationship to clinical response to SGN-CD48A. Assess biomarkers in relation to response, toxicity, and resistance to SGN-CD48A.

Inclusion Criteria

  • Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])
  • Participants must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
  • Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Adequate hematologic, renal, and hepatic function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 3 months
  • A negative pregnancy test (for females of childbearing potential)
  • Must provide written consent

  • Exclusion Criteria

  • Pre-existing peripheral neuropathy Grade 2 or higher
  • History of malignancy other than MM within the past 3 years
  • Active cerebral/meningeal disease related to the underlying malignancy
  • Uncontrolled Grade 3 or higher infection
  • Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
  • Previous allogeneic stem cell transplant
  • History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
  • Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
  • Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
  • Females who are pregnant or breastfeeding