A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast 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 paclitaxel.

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 paclitaxel. 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 Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Vantictumab combined with paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Age ≥18 years Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease o Patients with breast cancer overexpressing HER2 are not eligible. Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry Adequate hematologic and end-organ function Evaluable or measurable disease per RECIST v1.1 For women of childbearing potential, agreement to use two effective forms of contraception Exclusion Criteria: Known significant dose delays during prior treatment with a taxane due to drug-related toxicities Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment

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

Sexes Eligible for Study
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Female

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: Vantictumab combined with paclitaxel<br>Drug: vantictumab combined with paclitaxel - administered intravenously | Drug: Vantictumab combined with paclitaxel<br>* Vantictumab combined with paclitaxel will be administered IV.<br>* Other names: (OMP-18R5);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer | The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel | Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer | Apparent half life, AUC, clearance, volume of distribution | Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Recurrent, Metastatic Breast Cancer