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A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

Phase 1
18 Years
Open (Enrolling)
Renal Cell Adenocarcinoma, Clear Cell Renal Carcinoma, Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma

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Trial Information

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 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 in subjects with in subjects with relapsed /
refractory cc RCC, and Part 2 is aimed at evaluating safety, tolerability, PK and response
rate. Up to 40 subjects may be enrolled in Part 1, and up to 20 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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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)

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

May 2014

Related Keywords:

  • Renal Cell Adenocarcinoma
  • Clear Cell Renal Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Amgen
  • Phase 1
  • First in Human
  • Relapsed / Refractory Renal Cell Carcinoma (RCC)
  • Kidney Cancer
  • Clinical Trial
  • Antibody drug conjugate (ADC)
  • Open-label
  • Oncology
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Phoenix, Arizona  85012
Research Site Mesa, Arizona  
Research Site Branson, Missouri