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This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR+ Solid Tumor | Experimental | EGFR+ Solid Tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMGN289 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 2 years | |
| Area under the plasma concentration versus time curve | Determine the amount of IMGN289 in participants blood (pharmacokinetics) | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Vergara-Silva, MD | ImmunoGen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Peak plasma concentration (Cmax) of IMGN289 | Determine the amount of IMGN289 in participants blood (pharmacokinetics) | Up to 2 years |
| Presence of Human Anti Human Antibody and Human Anti Drug Antibody | Assess whether participants develop an immune response to IMGN289 | Up to 2 years |
| Tumor measurements per RECIST 1:1 | Assess preliminary anti-tumor activity | Up to 2 years |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| D018307 |
| Neoplasms, Squamous Cell |