Overview

This trial is active, not recruiting.

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
Treatment ags-16c3f
Phase phase 1
Sponsor Agensys, Inc.
Start date July 2012
End date December 2016
Trial size 34 participants
Trial identifier NCT01672775, AGS-16C3F-12-2

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Renal Cell Carcinoma subjects with clear and non-clear histology
ags-16c3f
intravenous (IV) infusion
(Experimental)
Expansion Cohort
ags-16c3f
intravenous (IV) infusion
(Experimental)
Expansion Cohort
ags-16c3f
intravenous (IV) infusion

Primary Outcomes

Measure
Incidence of Adverse Events
time frame: 24 months

Secondary Outcomes

Measure
Pharmacokinetic profile for total antibody (TAb), antibody drug conjugate (ADC), and monomethyl auristatin F (MMAF): Ceoi or Cmax, Ctrough, Tmax, AUCτ, t1/2, CL, and Vss
time frame: Days 1, 2, 3, 4, 8, 15, 22, 43, 64, 65, 66, 67, 71, 78, and 92
Incidence of antidrug antibody formation to human native antibody (AGS-16C) and antibody drug conjugate (AGS-16C3F)
time frame: 24 months
Tumor response: objective response rate
time frame: 24 months
Tumor response: disease control rate
time frame: 24 months
Tumor response: Changes in bone scans
time frame: Baseline, Week 13 and every 12 weeks thereafter

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 1, Open Label, Multi-center 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.