- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497821
AMG 172 First in Human Study in Patients With Kidney Cancer
March 23, 2016 updated by: Amgen
A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma
This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies.
The purpose of the study is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective response rate in patients with ccRCC receiving AMG 172.
The study will be conducted in two Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This First in- human study of AMG 172 will be conducted in two parts: Part 1 (dose exploration) and Part 2 (dose expansion).
Part 1 of the study is aimed at evaluating the safety, tolerability and PK of AMG 172 given every two weeks and every three weeks in subjects with relapsed / refractory cc RCC, and Part 2 is aimed at evaluating safety, tolerability, PK and response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing.
Up to 48 subjects may be enrolled in Part 1, and up to 30 subjects may be enrolled in Part 2. The dose of AMG 172 utilized in Part 2 will be dependent upon data obtained in Part 1 of the study.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Villejuif, France, 94805
- Research Site
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Heidelberg, Germany, 69120
- Research Site
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Arizona
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Scottsdale, Arizona, United States, 85258
- Research Site
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Missouri
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St Louis, Missouri, United States, 63110
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy
- Measurable disease per RECIST 1.1 criteria. Subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Willing to provide tumor samples and / or slides
Hematological function, as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
- Platelet count ≥ 100 x 10^9/L;
- Hemoglobin > 9 g/dL
- Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
Hepatic function, as follows:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN;
- Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);
- Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation)
- Other inclusion criteria may apply
Exclusion Criteria:
- Known primary central nervous system (CNS) tumors or brain metastases
- History of bleeding diathesis
- Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension in the opinion of the investigator
- Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
- A baseline ECG QTcF > 470 msec
- Known positive test for human immunodeficiency virus (HIV)
- Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
- Other exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dose exploration
Pre-specified nominal doses are proposed in the dose exploration at two dosing frequencies: every two weeks and every three weeks.
Intermediate doses may also be used if required based on the Continuous Reassessment Method (CRM) design.
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AMG 172 is an antibody drug conjugate
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Experimental: Dose expansion
Dose and dosing frequency selected from Part 1 dose exploration.
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AMG 172 is an antibody drug conjugate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs
Time Frame: 28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)
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28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)
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PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2)
Time Frame: 12 time points up to 8 weeks
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12 time points up to 8 weeks
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Objective response rate for subjects treated at MTD based on RECIST 1.1
Time Frame: 3 years
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3 years
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The MTD for at least one of two dosing schedules: every two weeks or every three weeks
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Development of human anti-human antibody against AMG 172
Time Frame: 1 year
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1 year
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Objective response rate for subjects not treated at MTD based on RECIST 1.1
Time Frame: 3 years
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3 years
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Clinical benefit as measured by duration of response per RECIST 1.1
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 20, 2011
First Posted (Estimate)
December 23, 2011
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 23, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20090515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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