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
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
1 other identifier
interventional
34
2 countries
9
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2012
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2012
CompletedFirst Posted
Study publicly available on registry
August 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2017
CompletedNovember 1, 2024
October 1, 2024
4.6 years
August 22, 2012
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
24 months
Secondary Outcomes (5)
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
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)
24 months
Tumor response: objective response rate
24 months
Tumor response: disease control rate
24 months
Tumor response: Changes in bone scans
Baseline, Week 13 and every 12 weeks thereafter
Study Arms (8)
Cohort 1 AGS-16C3F highest dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
Cohort 0 AGS-16C3F higher dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
Cohort (-1) AGS-16C3F high dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
Cohort (-2) AGS-16C3F middle dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
Cohort (-3) AGS-16C3F low dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
Cohort (-4) AGS-16C3F lowest dose
EXPERIMENTALRenal Cell Carcinoma subjects with clear and non-clear histology
AGS-16C3F in RCC Subjects with Clear Cell Histology
EXPERIMENTALExpansion Cohort
AGS-16C3F in RCC Subjects with Papillary Histology
EXPERIMENTALExpansion Cohort
Interventions
intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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:
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agensys, Inc.lead
Study Sites (9)
Site US00005 University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Site US00003 Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Site US00004 Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Site US00002 Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Site US00001 Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Site CA00006 Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Site CA00008 British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Site CA00009 London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
Site CA00007 Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Agensys, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2012
First Posted
August 27, 2012
Study Start
July 18, 2012
Primary Completion
February 21, 2017
Study Completion
February 21, 2017
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.