A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma
- Registration Number
- NCT02954796
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
- Detailed Description
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.
In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
- Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
- Age 18 years or older.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy greater than 3 months.
- Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
- Measurable 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 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
- Adequate hematologic, renal, and hepatic function
- A negative pregnancy test (for females of childbearing potential).
- Patients must provide written informed consent.
- Other invasive malignancy within the past 3 years.
- Active cerebral/meningeal disease related to the underlying malignancy.
- Active Grade 3 or higher infection.
- Known to be positive for HIV or known to have active hepatitis B or C.
- Previous allogeneic stem cell transplant.
- Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
- Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
- Females who are pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description (Dose Escalation) Cohort -1 - 6 SGN-CD352A SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
- Primary Outcome Measures
Name Time Method Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) Through 1 month following last dose. Incidence of dose-limiting toxicity During Cycle 1 (Trial Days 1-28)
- Secondary Outcome Measures
Name Time Method Overall survival Up to approximately 3 years Duration of objective response Up to approximately 3 years Duration of complete response Up to approximately 3 years Progression-free survival Up to approximately 3 years Blood concentrations of SGN-CD352A and metabolites Up to approximately 3 years Complete response rate Up to approximately 3 years Incidence of antitherapeutic antibodies (ATA) Up to approximately 3 years Objective response rate Up to approximately 3 years
Trial Locations
- Locations (11)
Winship Cancer Institute / Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
🇺🇸Dallas, Texas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Holden Comprehensive Cancer Center / University of Iowa
🇺🇸Iowa City, Iowa, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States