A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
- Registration Number
- NCT01015911
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Pathologically-confirmed diagnosis of NHL or RCC
- Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
- Confirmed CD70 expression
- Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC
- Previously received an allogeneic transplant
- History of another primary malignancy that has not been in remission for at least 3 years
- Prior anti-CD70-directed therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SGN-75 SGN-75
- Primary Outcome Measures
Name Time Method Incidence of adverse events and laboratory abnormalities Through 1 month following last dose
- Secondary Outcome Measures
Name Time Method Duration of response, progression-free survival Every 3 months until progression of disease or initiation of new treatment for cancer Blood concentrations of SGN-75 and metabolites Through 1 month following last dose Incidence of antitherapeutic antibodies Through 1 month following last dose Best clinical response Every 2 months
Trial Locations
- Locations (9)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UCLA Medical Center / University of California at Los Angeles
🇺🇸Los Angeles, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States