A Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Previously Untreated Stage IV Pancreatic Cancer

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.

Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into the study.

Inclusion Criteria:

• Signed Informed Consent Form
• Age ≥18 years
• Histologically documented Stage IV ductal adenocarcinoma of the pancreas
• Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
• ECOG performance status of 0 or 1
• Adequate hematologic and end-organ function
• Evaluable or measurable disease per RECIST v1.1
• For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

• Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
• Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
• Known hypersensitivity to any component of study treatments
• Known brain metastases, uncontrolled seizure disorder, or active neurologic disease