Safety Study of SGN-CD70A in Cancer Patients

April 18, 2018 updated by: Seagen Inc.

A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University Of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center / University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Cancer Institute
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University / University Hospitals Case Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania / Perelman Center for Advanced Medicine
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina/Hollings Cancer Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology - Austin Midtown
      • Houston, Texas, United States, 77030
        • Methodist Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance / University of Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Through 1 month following last dose
Through 1 month following last dose
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose
Through 1 month following last dose

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A
Time Frame: Through 1 month following last dose
Through 1 month following last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Elaina Gartner, MD, Seagen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 13, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN70A-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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