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

Astellas

Status and phase: Completed; Phase 1

Conditions: Ovarian Neoplasms; Carcinoma; Ovarian Cancer; Ovarian Diseases

Treatments: Biological: AGS-8M4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816764

2008001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

1. AGS-8M4 Dose 1

Experimental group

Treatment:

Biological: AGS-8M4

2. AGS-8M4 Dose 2

Experimental group

Treatment:

Biological: AGS-8M4

3. AGS-8M4 Dose 3

Experimental group

Treatment:

Biological: AGS-8M4

4. AGS-8M4 Dose 4

Experimental group

Treatment:

Biological: AGS-8M4