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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004865-33 | EudraCT Number |
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This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation and dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LJM716 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLTs) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 4 months | |
| Serious adverse events | 4 months | |
| Pharmacodynamic response to LJM716 in tumor tissue |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center University of Chicago (16) | Chicago | Illinois | 60546 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28899363 | Derived | Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6. |
| Label | URL |
|---|---|
| Results for CLJM716X2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| 3 months |
| Frequency of partial responses, complete responses and stable disease according to RECIST | every 2 months |
| Serum concentration of antibodies to LJM716 | 18 months |
| Progression-free survival | 18 months |
| Duration of response | 18 months |
| Serum concentration of LJM716, | 4 months |
| Massachusetts General Hospital SC-5 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| University of Texas/MD Anderson Cancer Center UT MD | Houston | Texas | 77030-4009 | United States |
| University of Utah / Huntsman Cancer Institute Huntsman | Salt Lake City | Utah | 84103 | United States |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| C000619694 | elgemtumab |
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