Safety Study of SGN-CD70A in Cancer Patients
- Conditions
- Diffuse, Large B-Cell, LymphomaFollicular Lymphoma, Grade 3Mantle-Cell LymphomaRenal Cell Carcinoma
- Interventions
- Registration Number
- NCT02216890
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
- Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
- Confirmed positive CD70 expression on tumor tissue
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate baseline hematologic, pulmonary, renal, and hepatic function
- Measurable disease
- Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on tumor tissue obtained after the treatment
- Patients <100 days since prior allogeneic stem cell transplant
- Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease progression on the prior treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SGN-CD70A SGN-CD70A -
- Primary Outcome Measures
Name Time Method Incidence of adverse events Through 1 month following last dose Incidence of laboratory abnormalities Through 1 month following last dose
- Secondary Outcome Measures
Name Time Method Blood concentrations of SGN-CD70A and metabolites Through 3 to 6 weeks after dosing Incidence of antitherapeutic antibodies Through 1 month following last dose Objective response rate Through 1 month following last dose Progression-free survival Approximately 3 years Duration of response Approximately 3 years
Trial Locations
- Locations (17)
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
Medical University of South Carolina/Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania / Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Case Western Reserve University / University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Methodist Cancer Center
🇺🇸Houston, Texas, United States