Status:
COMPLETED
AMG 172 First in Human Study in Patients With Kidney Cancer
Lead Sponsor:
Amgen
Conditions:
Renal Cell Adenocarcinoma
Clear Cell Renal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 refrac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01497821
Start Date
January 1 2012
End Date
January 1 2015
Last Update
March 25 2016
Active Locations (4)
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1
Research Site
Scottsdale, Arizona, United States, 85258
2
Research Site
St Louis, Missouri, United States, 63110
3
Research Site
Villejuif, France, 94805
4
Research Site
Heidelberg, Germany, 69120