Safety Study of SGN-CD70A in Cancer Patients

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216890
• Other study ID #: SGN70A-001
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2014
• Last updated: April 18, 2018
• Start date: August 2014
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2018
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-CD70A
Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UNC Lineberger Comprehensive Cancer Center / University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina/Hollings Cancer Center	Charleston	South Carolina
United States	University of Cincinnati Cancer Institute	Cincinnati	Ohio
United States	Case Western Reserve University / University Hospitals Case Medical Center	Cleveland	Ohio
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Methodist Cancer Center	Houston	Texas
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois
United States	University of Pennsylvania / Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	James P. Wilmot Cancer Center / University of Rochester Medical Center	Rochester	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A		Through 1 month following last dose
Primary	Incidence of adverse events		Through 1 month following last dose
Primary	Incidence of laboratory abnormalities		Through 1 month following last dose
Secondary	Blood concentrations of SGN-CD70A and metabolites		Through 3 to 6 weeks after dosing
Secondary	Incidence of antitherapeutic antibodies		Through 1 month following last dose
Secondary	Objective response rate		Through 1 month following last dose
Secondary	Progression-free survival		Approximately 3 years
Secondary	Duration of response		Approximately 3 years