Carcinoma, Renal CellPhase 1NCT01672775
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 study testing AGS-16C3F in people with Carcinoma, Renal Cell and Renal Cell Carcinoma of Papillary Histology, run by Agensys, Inc. at 9 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Renal Cell Carcinoma of Papillary Histology, Renal Cell Carcinoma With Clear Cell Histology
- What is being tested?
- AGS-16C3F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 18 Jul 2012to 21 Feb 2017
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States5 sites
Site US00005 University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Site US00004 Roswell Park Cancer Institute
Buffalo, New York, 14263
Site US00003 Karmanos Cancer Institute
Detroit, Michigan, 48201
Site US00002 Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Site US00001 Seattle Cancer Care Alliance
Seattle, Washington, 98109
Canada4 sites
Site CA00006 Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Site CA00009 London Health Sciences Centre
London, Ontario, N6A 4L6
Site CA00007 Jewish General Hospital
Montreal, Quebec, H3T 1E2
Site CA00008 British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
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
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).
Read the 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
- Being tested
- AGS-16C3F
- Keywords
- Renal Cell Carcinoma, AGS-16C3F, Pharmacokinetics of AGS-16C3F
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-16C3FDrug
intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 AGS-16C3F highest dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| Cohort 0 AGS-16C3F higher dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| Cohort (-1) AGS-16C3F high dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| Cohort (-2) AGS-16C3F middle dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| Cohort (-3) AGS-16C3F low dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| Cohort (-4) AGS-16C3F lowest dose | Experimental | Renal Cell Carcinoma subjects with clear and non-clear histology Receives: Drug: AGS-16C3F |
| AGS-16C3F in RCC Subjects with Clear Cell Histology | Experimental | Expansion Cohort Receives: Drug: AGS-16C3F |
| AGS-16C3F in RCC Subjects with Papillary Histology | Experimental | Expansion Cohort Receives: Drug: AGS-16C3F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: 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
Concentration at end of infusion (Ceoi) or maximum observed concentrations (Cmax), Trough concentration (Ctrough), time to maximum concentration (Tmax), partial area under the serum concentration-time curve (AUCτ), terminal or apparent half-life (t1/2), systemic clearance (CL), and volume of distribution at steady state (Vss)
Measured: 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)
Measured: 24 months
Tumor response: objective response rate
Determined from the subjects' best response and will include complete response (CR) and partial response (PR)
Measured: 24 months
Tumor response: disease control rate
Determined from the subjects' best response will include complete response (CR) partial response (PR), and stable disease (SD)
Measured: 24 months
Tumor response: Changes in bone scans
Measured: Baseline, Week 13 and every 12 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start18 Jul 2012
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agensys, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Agensys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672775
- Sponsor's protocol ID
- AGS-16C3F-12-2
- Status last verified
- Oct 2024
- First submitted
- 22 Aug 2012
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.