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Trial was terminated due to the need to re-formulate the study drug.
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| Name | Class |
|---|---|
| Agensys, Inc. | INDUSTRY |
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This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. AGS-16M18 Dose 1 | Experimental |
| |
| 2. AGS-16M18 Dose 2 | Experimental |
| |
| 3. AGS-16M18 Dose 3 | Experimental |
| |
| 4. AGS-16M18 Dose 4 | Experimental |
| |
| 5. AGS-16M18 Dose 5 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGS-16M18 | Biological | IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Throughout the treatment | |
| Assessment of PK variables | Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-AGS-16M18 antibody formation | Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose | |
| Changes in tumor status | Week 5, week 8, every 8 weeks during extension 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 | 21231 | United States | |||
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D007674 | Kidney Diseases |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| New York |
| New York |
| 10021 |
| United States |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |