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Safety Study of SGN-CD70A in Cancer Patients

Primary Purpose

Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-CD70A
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • University of Michigan Comprehensive Cancer Center
  • Karmanos Cancer Institute / Wayne State University
  • Comprehensive Cancer Centers of Nevada
  • James P. Wilmot Cancer Center / University of Rochester Medical Center
  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
  • University of Cincinnati Cancer Institute
  • Case Western Reserve University / University Hospitals Case Medical Center
  • University of Pennsylvania / Perelman Center for Advanced Medicine
  • Medical University of South Carolina/Hollings Cancer Center
  • Texas Oncology - Austin Midtown
  • Methodist Cancer Center
  • University of Texas Health Science Center at San Antonio
  • Seattle Cancer Care Alliance / University of Washington
  • Northwest Cancer Specialists, P.C.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGN-CD70A

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events
Incidence of laboratory abnormalities

Secondary Outcome Measures

Blood concentrations of SGN-CD70A and metabolites
Incidence of antitherapeutic antibodies
Objective response rate
Progression-free survival
Duration of response

Full Information

First Posted
August 12, 2014
Last Updated
April 18, 2018
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02216890
Brief Title
Safety Study of SGN-CD70A in Cancer Patients
Official Title
A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3
Keywords
Renal Cell Carcinoma, Mantle-Cell Lymphoma, Diffuse, Large B-Cell, Lymphoma, Follicular Lymphoma, Grade 3, Antibody-Drug Conjugate, CD70 Antigen, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGN-CD70A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-CD70A
Intervention Description
Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Through 1 month following last dose
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose
Secondary Outcome Measure Information:
Title
Blood concentrations of SGN-CD70A and metabolites
Time Frame
Through 3 to 6 weeks after dosing
Title
Incidence of antitherapeutic antibodies
Time Frame
Through 1 month following last dose
Title
Objective response rate
Time Frame
Through 1 month following last dose
Title
Progression-free survival
Time Frame
Approximately 3 years
Title
Duration of response
Time Frame
Approximately 3 years
Other Pre-specified Outcome Measures:
Title
Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaina Gartner, MD
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
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
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
James P. Wilmot Cancer Center / University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Case Western Reserve University / University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pennsylvania / Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina/Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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
Facility Name
Northwest Cancer Specialists, P.C.
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States

12. IPD Sharing Statement

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Safety Study of SGN-CD70A in Cancer Patients

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