A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.

Detailed Description
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All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. A disease assessment will be performed at study week 9 (+/- 3 days). The assessment will be based on clinical signs and symptoms, changes in radiographic images, and changes in CA-125 levels. Subjects without evidence of disease progression may continue to receive AGS-8M4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression intolerability of AGS-8M4 or consent withdrawal. For subjects that continue dosing, disease assessments will be performed every 8 weeks during the extended treatment period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-8M4.

Official Title
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A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-8M4 Given as Monotherapy in Subjects With Advanced Ovarian Cancer

Conditions
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Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms

Intervention / Treatment
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* Biological: AGS-8M4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime Exclusion Criteria: No epithelial ovarian tumors of low malignant potential Active infection requiring treatment with systemic anti-infectives within 72 hours of screening Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer) Prior monoclonal antibody therapy

Ages Eligible for Study
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Minimum Age: 18 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: 1. AGS-8M4 Dose 1<br> | Biological: AGS-8M4<br>* IV Infusion<br>|
| Experimental: 2. AGS-8M4 Dose 2<br> | Biological: AGS-8M4<br>* IV Infusion<br>|
| Experimental: 3. AGS-8M4 Dose 3<br> | Biological: AGS-8M4<br>* IV Infusion<br>|
| Experimental: 4. AGS-8M4 Dose 4<br> | Biological: AGS-8M4<br>* IV Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Throughout the treatment | 
| Assessment of PK variables |  | Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anti-AGS-8M4 antibody formation |  | Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose | 
| Changes in tumor status per RECIST |  | Week 9, and every 8 weeks during the extended treatment period | 
| Changes in CA-125 levels |  | Week 9, and every 8 weeks during the extended treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, phase 1, carcinoma, pharmacokinetics, safety, ovarian