3P-13-2: 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
DescriptionThis 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 in patients with previously untreated stage IV Pancreatic Cancer.Up to approximately 34 patients may be enrolled into the study out of which 8 will be enrolled from USC.Vantictumab is a fully human IgG2 monoclonal antibody that binds the FZD1, 2, 5, 7, and 8 receptors and inhibits Wnt signaling to target cancer stem cells.Pancreatic cancer is a rational target for vantictumab because hyperactivity of Wnt signaling has been strongly linked to the development and progression of pancreatic cancer. Vantictumab combined with gemcitabine showed anti-tumor activity superior to that of gemcitabine alone in a panel of patient-derived xenograft models Based on a recent trial showing a positive effect of nab-paclitaxel in combination with gemcitabine, activity of vantictumab in combination with gemcitabine plus nab-paclitaxel will be studied in this trial.Primary objective of this study is to evaluate the safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer.Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel mg/m2 and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle. Depending on safety in this study, additional lower or intermediate dose levels may be evaluated.Study period will last approximately 12 to 21 months.The primary efficacy endpoint is objective response, defined as a complete or partial response, on the basis of investigator assessment using RECIST v1.1.
Inclusion 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
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.