A Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary Histology

NCT ID: NCT01672775

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-18
• Study Completion Date: 2017-02-21

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics and assess the immunogenicity and effectiveness of AGS-16C3F in subjects with renal cell cancer (RCC).

Detailed Description

The study has two components. The first aims to establish a safe dose for AGS-16C3F. Once identified, the safety and effectiveness will be tested in additional subjects with either clear cell or papillary histology in expanded cohorts.

Conditions

Carcinoma, Renal Cell; Renal Cell Carcinoma of Papillary Histology; Renal Cell Carcinoma With Clear Cell Histology; Renal Cell Carcinoma With Non-Clear Cell Histology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 AGS-16C3F highest dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Cohort 0 AGS-16C3F higher dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Cohort (-1) AGS-16C3F high dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Cohort (-2) AGS-16C3F middle dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Cohort (-3) AGS-16C3F low dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Cohort (-4) AGS-16C3F lowest dose

Renal Cell Carcinoma subjects with clear and non-clear histology

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

AGS-16C3F in RCC Subjects with Clear Cell Histology

Expansion Cohort

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

AGS-16C3F in RCC Subjects with Papillary Histology

Expansion Cohort

Group Type: EXPERIMENTAL

AGS-16C3F

Intervention Type: DRUG

intravenous (IV) infusion

Interventions

AGS-16C3F

intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.

• Tumors with clear cell histology: subject must have progressed after at least one anti-vascular endothelial growth factor receptor (anti-VEGFR) therapy
• Tumors with non-clear cell histology must be ectonucleotide pyrophosphatase/phosphodiesterase family member 3 (ENPP3) positive at pre-screening. This sub-group does not have any prior therapy requirement.
• Dose expansion cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or papillary histology

• Tumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapy
• Tumors with papillary histology: includes unclassified histology with papillary features and must be ENPP3 positive at pre-screening. This sub-group does not have any prior therapy requirement.
• Measurable disease according to Response Criteria for Solid Tumors (RECIST Version 1.1)
• Eastern Cooperative Group (ECOG) performance status of 0-1
• Hematologic function, as follows:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 9 g/dL (transfusions are allowed)
• Renal function, as follows:

• creatinine ≤ 1.5 x upper limit of normal (ULN), or calculated glomerular filtration rate (GFR) > 50 mL/min if creatinine > 1.5x ULN
• Hepatic function, as follows:

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5x ULN if known liver metastases
• Total bilirubin ≤1.5 x ULN
• International normalized ratio (INR) < 1.3 (or ≤ 3.0 if on therapeutic anticoagulation)
• Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study and for 4 weeks after the last AGS-16C3F infusion administration

Exclusion Criteria

• Current uncontrolled central nervous system (CNS) metastasis or malignant brain tumors
• Use of any investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening. No time limit applies to the use of marketed drugs approved for this indication provided that the subject has progressed on the treatment and all toxicities attributable to the drug have resolved or returned to baseline
• Known sensitivity to any of the ingredients of the investigational product AGS-16C3F
• History of thromboembolic events and bleeding disorders ≤3 months (e.g., (deep vein thrombosis) DVT or pulmonary embolism (PE))
• Active angina or Class III or IV Congestive Heart Failure (CHF) (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by outpatient medication.
• Major surgery within 4 weeks of study enrollment
• Women who are pregnant (confirmed by positive pregnancy test) or lactating
• Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen.
• Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening.
• History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agensys, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Agensys, Inc.

Locations

Site US00005 University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site US00003 Karmanos Cancer Institute

Detroit, Michigan, United States

Site US00004 Roswell Park Cancer Institute

Buffalo, New York, United States

Site US00002 Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site US00001 Seattle Cancer Care Alliance

Seattle, Washington, United States

Site CA00006 Cross Cancer Institute

Edmonton, Alberta, Canada

Site CA00008 British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site CA00009 London Health Sciences Centre

London, Ontario, Canada

Site CA00007 Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Related Links

https://astellasclinicalstudyresults.com/patientStudySearch.aspx?RID=;;;AGS-16C3F-12-2

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

AGS-16C3F-12-2

Identifier Type: -

Identifier Source: org_study_id