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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pancreatic Cancer, Stage IV Pancreatic Cancer

Intervention / Treatment
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* Drug: Vantictumab
* Drug: Nab-Paclitaxel
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vanctictumab (OMP-18R5)<br>Vantictumab will be administered by intravenous (IV) infusion. | Drug: Vantictumab<br>* Administered intravenous (IV) infusion.<br>* Other names: OMP-18R5;Drug: Nab-Paclitaxel<br>* Nab-Paclitaxel will be administered by intravenous (IV) infusion.<br>Drug: Gemcitabine<br>* Gemcitabine will be administered by intravenous (IV) infusion.<br>|
| Experimental: Nab-Paclitaxel<br>Nab-Paclitaxel will be administered by intravenous (IV) infusion. | Drug: Vantictumab<br>* Administered intravenous (IV) infusion.<br>* Other names: OMP-18R5;Drug: Nab-Paclitaxel<br>* Nab-Paclitaxel will be administered by intravenous (IV) infusion.<br>Drug: Gemcitabine<br>* Gemcitabine will be administered by intravenous (IV) infusion.<br>|
| Experimental: Gemcitabine<br>Gemcitabine will be administered by intravenous (IV) infusion. | Drug: Vantictumab<br>* Administered intravenous (IV) infusion.<br>* Other names: OMP-18R5;Drug: Nab-Paclitaxel<br>* Nab-Paclitaxel will be administered by intravenous (IV) infusion.<br>Drug: Gemcitabine<br>* Gemcitabine will be administered by intravenous (IV) infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer | The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel | Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer | Apparent half life, AUC, clearance, volume of distribution | Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Stage IV Pancreatic Cancer