Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U3-1287 (AMG888) | Drug | IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors | Lenth of study | |
| To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors | Lenth of study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters | Length of study | |
| Pharmacodynamic Parameters | Length of study | |
| Human anti-human antibody profile for U3-1287(AMG888) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Faber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23591447 | Derived | LoRusso P, Janne PA, Oliveira M, Rizvi N, Malburg L, Keedy V, Yee L, Copigneaux C, Hettmann T, Wu CY, Ang A, Halim AB, Beckman RA, Beaupre D, Berlin J. Phase I study of U3-1287, a fully human anti-HER3 monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2013 Jun 1;19(11):3078-87. doi: 10.1158/1078-0432.CCR-12-3051. Epub 2013 Apr 16. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C564369 | Lethal Congenital Contracture Syndrome 2 |
| C565323 | Fibromatosis, Gingival, 2 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C585471 | patritumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Length of study |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Memorial Sloan-Kettering Cancer Centre | New York | New York | 10065 | United States |
| Vanderbilt Ingram cancer Centre | Nashville | Tennessee | 37232 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |