Back to resultsA Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-75
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD70, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Immunotherapy, Drug Therapy, monomethylauristatin F
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
- City of Hope National Medical Center
- UCLA Medical Center / University of California at Los Angeles
- Karmanos Cancer Institute / Wayne State University
- Mayo Clinic
- Memorial Sloan Kettering Cancer Center
- Sarah Cannon Research Institute
- MD Anderson Cancer Center / University of Texas
- Seattle Cancer Care Alliance / University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
SGN-75
Outcomes
Primary Outcome Measures
Incidence of adverse events and laboratory abnormalities
Secondary Outcome Measures
Best clinical response
Duration of response, progression-free survival
Blood concentrations of SGN-75 and metabolites
Incidence of antitherapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01015911
Brief Title
A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
Official Title
A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD70, Lymphoma, Non-Hodgkin, Carcinoma, Renal Cell, Immunotherapy, Drug Therapy, monomethylauristatin F
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
SGN-75
Intervention Type
Drug
Intervention Name(s)
SGN-75
Intervention Description
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg
Primary Outcome Measure Information:
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
Through 1 month following last dose
Secondary Outcome Measure Information:
Title
Best clinical response
Time Frame
Every 2 months
Title
Duration of response, progression-free survival
Time Frame
Every 3 months until progression of disease or initiation of new treatment for cancer
Title
Blood concentrations of SGN-75 and metabolites
Time Frame
Through 1 month following last dose
Title
Incidence of antitherapeutic antibodies
Time Frame
Through 1 month following last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Whiting, PharmD, BCOP
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
UCLA Medical Center / University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1678
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25142258
Citation
Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Invest New Drugs. 2014 Dec;32(6):1246-57. doi: 10.1007/s10637-014-0151-0. Epub 2014 Aug 22.
Results Reference
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A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma
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