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A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015911
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
Seattle Genetics, 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Lymphoma, Non-Hodgkin Drug: SGN-75 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: 1
Drug: SGN-75
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

Primary Outcome Measures :
  1. Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Best clinical response [ Time Frame: Every 2 months ]
  2. Duration of response, progression-free survival [ Time Frame: Every 3 months until progression of disease or initiation of new treatment for cancer ]
  3. Blood concentrations of SGN-75 and metabolites [ Time Frame: Through 1 month following last dose ]
  4. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015911

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
UCLA Medical Center / University of California at Los Angeles
Los Angeles, California, United States, 90095-1678
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Seattle Genetics, Inc.
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Study Director: Nancy Whiting, PharmD, BCOP Seattle Genetics, Inc.

Publications of Results:
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Responsible Party: Seattle Genetics, Inc. Identifier: NCT01015911    
Other Study ID Numbers: SGN75-001
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD70
Lymphoma, Non-Hodgkin
Carcinoma, Renal Cell
Drug Therapy
monomethylauristatin F
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs