A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.

Detailed Description
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This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..

Official Title
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A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Conditions
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Cancer Ovaries, Cancer Peritoneal, Cancer, Fallopian Tube

Intervention / Treatment
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* Drug: OMP-305B83
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer Measureable disease per response evaluation criteria (RECIST) v1.1 Prior bevacizumab Age > or = 21 years Adequate organ and marrow function For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease. Subjects with brain metastases Subjects with leptomeningial disease or neoplasms in the last 5 years Blood pressure >140/80 Significant intercurrent illness that will limit the patient's ability to participate in the study Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study Pregnant or nursing women New York Heart Association Classification II, III, or IV Inability to comply with study and follow up procedure

Ages Eligible for Study
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Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMP-305B83 plus paclitaxel<br> | Drug: OMP-305B83<br>* intravenous (in the vein) infusion<br>* Other names: bispecific monoclonal antibody;Drug: Paclitaxel<br>* administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dose limiting toxicities (DLT) | The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with 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 |
| --- | --- | --- |
| Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis. |  | Through study completion, an average of 6 months | 
| To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel |  | Through study completion, an average of 6 months | 
| Response Rate assessed by RECIST criteria 1.1 |  | At 56 day intervals while on treatment, through study completion, an average of 6 months | 
| Response Rate assessed by CA-125 criteria |  | At 28 day intervals while on treatment, through study completion, an average of 6 months | 
| Progression Free Survival |  | Up to 5 years |