Status:
TERMINATED
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma
Lead Sponsor:
Seagen Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 wa...
Detailed Description
This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts: 1. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03379584
Start Date
February 20 2018
End Date
August 23 2019
Last Update
September 18 2019
Active Locations (6)
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1
University of California at San Francisco
San Francisco, California, United States, 94134
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520
3
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
4
Mount Sinai Medical Center
New York, New York, United States, 10029