Safety Study of SGN-CD70A in Cancer Patients

NCT02216890 | Completed Phase 1

• 1 other identifier: SGN70A-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 17

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Through 1 month following last dose

• Incidence of laboratory abnormalities

  Through 1 month following last dose

Secondary Outcomes (5)

• Blood concentrations of SGN-CD70A and metabolites

  Through 3 to 6 weeks after dosing

• Incidence of antitherapeutic antibodies

  Through 1 month following last dose

• Objective response rate

  Through 1 month following last dose

• Progression-free survival

  Approximately 3 years

• Duration of response

  Approximately 3 years

Other Outcomes (1)

• Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A

  Through 1 month following last dose

Study Arms (1)

SGN-CD70A

EXPERIMENTAL

Drug: SGN-CD70A

Interventions

SGN-CD70A DRUG

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

SGN-CD70A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

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

Rochester, New York, 14642, United States

Location

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University / University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania / Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina/Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

Texas Oncology - Austin Midtown

Austin, Texas, 78705, United States

Location

Methodist Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

Northwest Cancer Specialists, P.C.

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Study Officials

• Elaina Gartner, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

US (17)