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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
AMG 172 is an antibody drug conjugate
Research Site
Scottsdale, Arizona, United States
Research Site
St Louis, Missouri, United States
Research Site
Villejuif, France
Research Site
Heidelberg, Germany
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)
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
Objective response rate for subjects treated at MTD based on RECIST 1.1
Time frame: 3 years
The MTD for at least one of two dosing schedules: every two weeks or every three weeks
Time frame: 3 years
Development of human anti-human antibody against AMG 172
Time frame: 1 year
Objective response rate for subjects not treated at MTD based on RECIST 1.1
Time frame: 3 years
Clinical benefit as measured by duration of response per RECIST 1.1
Time frame: 3 years
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