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

Stopped early · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03379584

Run by

Seagen Inc.

People needed

14

Starts

2018-02-20

Expected to finish

2019-08-23

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Mount Sinai Medical Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University of Pennsylvania / Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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