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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell, Lymphoma, Non-Hodgkin

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events and laboratory abnormalities

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:

Yes

Principal Investigator

Nancy Whiting, PharmD, BCOP

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN75-001

NCT ID:

NCT01015911

Start Date:

November 2009

Completion Date:

March 2012

Related Keywords:

  • Carcinoma, Renal Cell
  • Lymphoma, Non-Hodgkin
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD70
  • Lymphoma, Non-Hodgkin
  • Carcinoma, Renal Cell
  • Immunotherapy
  • Drug Therapy
  • monomethylauristatin F
  • Carcinoma
  • Carcinoma, Renal Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Mayo Clinic Rochester, Minnesota  55905
City of Hope National Medical Center Los Angeles, California  91010
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Sarah Cannon Research Institute Nashville, Tennessee  37203
Karmanos Cancer Institute / Wayne State University Detroit, Michigan  48201
MD Anderson Cancer Center / University of Texas Houston, Texas  77030-4003
UCLA Medical Center / University of California at Los Angeles Los Angeles, California  90095-1678
Seattle Cancer Care Alliance / University of Washington Seattle, Washington  98109-1023