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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002926-38 | EudraCT Number |
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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
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| Name | Class |
|---|---|
| Glenmark Pharmaceuticals S.A. | INDUSTRY |
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The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of GBR 1302 monotherapy in subjects with HER2 positive cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBR 1302 | Experimental | Dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD3/HER2 bispecific monoclonal antibody | Drug | Increasing doses, IV on day 1 and 15 of each 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Tolerated Dose (MTD) of GBR 1302 | Number of DLTs (dose limiting toxicities) after the first two administrations of study drug (i.e. Cycle 1) in each cohort | 28 Days |
| The relationship of the dose of GBR 1302 with the incidence, nature, and intensity of AEs according to CTCAEv4.03 | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) for solid tumors. | 2 cycles, 56 days | |
| Disease control rate (DCR) for solid tumors | 2 cycles, 56 days | |
| Duration of disease control (measured from drug start date to the date of disease progression or death for subjects who had CR or PR or SD during treatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Khazan, MD | Ichnos Sciences SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenmark Investigational Site 204 | Fairway | Kansas | 66205 | United States | ||
| Glenmark Investigational Site 209 |
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| At least 56 days |
| Maximum Concentration (Cmax) of GBR 1302 | 28 Days |
| Time to Maximum Concentration (Tmax) of GBR 1302 | 28 Days |
| Area Under Curve [AUC0-t and AUC0-tau] of GBR 1302 | 28 Days |
| Immunogenicity of GBR 1302 in terms of ADA formation assessed compared to baseline | 28 Days |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Glenmark Investigational Site 201 | Dallas | Texas | 75230 | United States |
| Glenmark Investigational Site 203 | Salt Lake City | Utah | 84112 | United States |
| Glenmark Investigational Site 103 | Berlin | 10117 | Germany |
| Glenmark Investigational Site 102 | Cologne | 50670 | Germany |
| Glenmark Investigational Site 101 | Dresden | 01307 | Germany |
| Glenmark Investigational Site 104 | Mainz | 55131 | Germany |