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
Description
Brief Summary
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.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact Judy Lam-Tran to learn more about where you can participate in this trial. Please use the contact form on the right side.