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| Name | Class |
|---|---|
| Agensys, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. AGS-8M4 Dose 1 | Experimental |
| |
| 2. AGS-8M4 Dose 2 | Experimental |
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| 3. AGS-8M4 Dose 3 | Experimental |
| |
| 4. AGS-8M4 Dose 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGS-8M4 | Biological | IV Infusion |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Agensys, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | 19111 | United States | |||
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Changes in CA-125 levels | Week 9, and every 8 weeks during the extended treatment period |
| New York |
| New York |
| 10021 |
| United States |
| New York | New York | 10032 | United States |
| D009371 | Neoplasms by Site |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |