A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors
Inclusion Criteria:
- Men and women ≥ 18 years old
- Must have a pathologically documented, and definitely diagnosed, advanced solid tumor
that is refractory to standard treatment, or for which no curative therapy is
available, or for subjects who refuse standard therapy
- Measurable disease by RECIST criteria
- Must be able to undergo MRI evaluation
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Competent to sign and date an Institutional Review Board approved informed consent
form
Exclusion Criteria:
- Presence of untreated or symptomatic primary central nervous system tumors or
metastases
- Presence of leukemia or myelodysplastic syndrome
- Subjects with head and neck cancer
- Previous hematopoietic stem cell transplant (allogeneic)
- Unresolved hematological toxicities > grade 1 with the exception of grade 2
lymphopenia and non-hematological toxicities > grade 1, excluding alopecia and grade
2 neuropathy, from prior anti-cancer therapy
- Myocardial infarction within 1 year before study day 1, or unstable or uncontrolled
disease/condition related to or affecting cardiac function
- History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year
before study
- Active peripheral vascular disease
- History of bleeding diathesis
- History of pulmonary hemorrhage or gross hemoptysis within 6 months before study
- Known history of adrenal hemorrhage
- Known positive test for human immunodeficiency virus infection, or active hepatitis B
or hepatitis C
- Major surgery within 1 month before study
- Prior treatment with any agent targeting the angiopoietin-Tie2 signaling pathway
- Concurrent antitumor treatment, except Lupron for subjects with prostate cancer and
selective estrogen receptor modulators (SERMS) for subjects with breast cancer,
within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1
- Known sensitivity to mammalian-derived products, bacterially-produced proteins, or
any of the products to be administered during dosing
- Investigational agent within 30 days before study
- Pregnant (eg, positive urine test) or breastfeeding
- Subjects of childbearing potential, or subject who has a partner of childbearing
potential, and is not using highly effective contraceptive precautions