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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004881-13 | EudraCT Number |
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This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LJM716 in combination with trastuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LJM716 | Drug | LJM716 |
| |
| Trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Dose Limiting Toxicities | Incidence of dose-limiting toxicities (DLTs) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Safety assessment | 4 months |
| Number of serious adverse events | Safety assessment | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLJM716X2102 from the Novartis Clinical Trials Website | View source |
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| Drug |
Trastuzumab |
|
| Pharmacodynamic response to LJM716 in tumor tissue | Post-treatment change from baseline in pHER3 levels in the tumor | 3 months |
| Progression-free survival | Efficacy assessment | 18 months |
| Duration of response | Efficacy assessment | 18 months |
| Serum concentration of anti-LJM716 antibodies | Incidence of antibodies against LJM716 | 4 months |
| Serum concentration of LJM716 when administered in combination with trastuzumab | PK profile | 4 months |
| Frequency of partial responses according to Response Evaluation Criteria In Solid Tumors (RECIST) | Efficacy assessment | every 2 months up to 18 months |
| Frequency of complete responses according to RECIST | Efficacy assessment | every 2 months up to 18 months |
| Frequency of stable disease according to RECIST | Efficacy assessment | every 2 months up to 18 months |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19111 | United States |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Saint-Herblain | 44805 | France |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Valencia | Valencia | 46010 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000619694 | elgemtumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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