A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors
Inclusion Criteria:
- Part 1: Histologically or cytologically confirmed, locally advanced or metastatic,
treatment-refractory solid tumors
- Part 2: Histologically or cytologically confirmed, locally advanced or metastatic:
NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens),
Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1
prior treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or
Sarcoma (up to 2 prior treatment regimens), according to cohort availability
- Eastern Cooperative Group (ECOG performance status of 0 or 1
- Women or men ≥16 years of age
- Adequate hematology, renal, hepatic, coagulation and glycemic function.
Exclusion Criteria:
- Presence of uncontrolled central nervous system (CNS) disease
- Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved
anticancer proteins/antibodies therapy ≤28 days before enrollment.
- Prior treatment with death receptor agonists (including but not limited to
rhApo2L/TRAIL [AMG951], apomab, mapatumumab, lexatumumab, CS-1008)
- Prior treatment with IGF receptor antagonists (including but not limited to CP-751,
871, MK0646, AVE1642 or IMC-A12)