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Study Complete
Sponsor ID
20090515

AMG 172 first in human study in patients with kidney cancer

Sponsor ID
20090515
Clinicaltrials.gov ID
NCT01497821
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 172
Type
Interventional
Masking
None (Open Label)
Enrollment
37
Additional Study Details

Protocol Summary

Primary Outcome Measures

Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs

Timeframe: 28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)

PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2)

Timeframe: 12 time points up to 8 weeks

Objective response rate for subjects treated at MTD based on RECIST 1.1

Timeframe: 3 years

The MTD for at least one of two dosing schedules: every two weeks or every three weeks

Timeframe: 3 years

Secondary Outcome Measures

Development of human anti-human antibody against AMG 172

Timeframe: 1 year

Objective response rate for subjects not treated at MTD based on RECIST 1.1

Timeframe: 3 years

Clinical benefit as measured by duration of response per RECIST 1.1

Timeframe: 3 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Scottsdale, AZ, United States, 85258
Status
Recruiting
Location
Research Site
St Louis, MO, United States, 63110
Status
Recruiting
Location
Research Site
Villejuif, France, 94805
Status
Recruiting
Location
Research Site
Heidelberg, Germany, 69120
Status
Recruiting
Study Info
Age
18+ years
Condition
  • Kidney Cancer
    • Sex
    All
    Trial Dates
    Jan 2012 - Nov 2014
    Inclusion and Exclusion Criteria
    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: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; 2. Platelet count ≥ 100 x 10^9/L; 3. 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: 1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN; 2. 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); 3. 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