A Safety Study of SGN-CD48A in Patients With Multiple Myeloma

• Status: Terminated
• Trial end date: 2019-08-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.

Criteria

Inclusion Criteria:

• Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])

• Patients 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)

• Patients 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