Clinical trial NCT02216890: 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
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Through 1 month following last dose
measure: Incidence of laboratory abnormalities
timeFrame: Through 1 month following last dose
Secondary outcomes:
measure: Blood concentrations of SGN-CD70A and metabolites
timeFrame: Through 3 to 6 weeks after dosing
measure: Incidence of antitherapeutic antibodies
timeFrame: Through 1 month following last dose
measure: Objective response rate
timeFrame: Through 1 month following last dose
measure: Progression-free survival
timeFrame: Approximately 3 years
measure: Duration of response
timeFrame: Approximately 3 years
Other outcomes:
measure: Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A
timeFrame: Through 1 month following last dose
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center / University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University / University Hospitals Case Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania / Perelman Center for Advanced Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina/Hollings Cancer Center
state: South Carolina
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown
state: Texas
city: Houston
country: United States
facility: Methodist Cancer Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Elaina Gartner, MD
role: STUDY_DIRECTOR
References: