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Safety Study of SGN-CD70A in Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT02216890
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Mantle-Cell Lymphoma Diffuse, Large B-Cell, Lymphoma Follicular Lymphoma, Grade 3 Drug: SGN-CD70A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017


Arm Intervention/treatment
Experimental: SGN-CD70A Drug: SGN-CD70A
Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)




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

Secondary Outcome Measures :
  1. Blood concentrations of SGN-CD70A and metabolites [ Time Frame: Through 3 to 6 weeks after dosing ]
  2. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]
  3. Objective response rate [ Time Frame: Through 1 month following last dose ]
  4. Progression-free survival [ Time Frame: Approximately 3 years ]
  5. Duration of response [ Time Frame: Approximately 3 years ]

Other Outcome Measures:
  1. Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A [ 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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT02216890


Locations
Show Show 17 study locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Elaina Gartner, MD Seattle Genetics, Inc.
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02216890    
Other Study ID Numbers: SGN70A-001
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Keywords provided by Seattle Genetics, Inc.:
Renal Cell Carcinoma
Mantle-Cell Lymphoma
Diffuse, Large B-Cell, Lymphoma
Follicular Lymphoma, Grade 3
Antibody-Drug Conjugate
CD70 Antigen
Drug Therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Carcinoma, Renal Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Lymphoma, Non-Hodgkin
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lymphoma, B-Cell