Safety Study of SGN-CD70A in Cancer Patients

NCT ID: NCT02216890

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma Mantle-Cell Lymphoma Diffuse, Large B-Cell, Lymphoma Follicular Lymphoma, Grade 3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SGN-CD70A

Group Type EXPERIMENTAL

SGN-CD70A

Intervention Type DRUG

Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)

Interventions

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SGN-CD70A

Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaina Gartner, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

James P. Wilmot Cancer Center / University of Rochester Medical Center

Rochester, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University / University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

University of Pennsylvania / Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina/Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Texas Oncology - Austin Midtown

Austin, Texas, United States

Site Status

Methodist Cancer Center

Houston, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States

Site Status

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SGN70A-001

Identifier Type: -

Identifier Source: org_study_id

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