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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004206-42 | EudraCT Number |
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The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas.
This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules.
The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas.
Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWN323 | Drug |
| ||
| PDR001 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) - Single Agent | Dose Limiting Toxicities | 21 days |
| Incidence of Dose Limiting Toxicities (DLTs) - Combination Agents | Dose Limiting Toxicities | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR), | 36 months | |
| Progression Free Survival (PFS) | per irRC and RECIST v1.1 or Cheson (2014) | 36 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 | Chicago | Illinois | 60637 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34389618 | Derived | Piha-Paul SA, Geva R, Tan TJ, Lim DW, Hierro C, Doi T, Rahma O, Lesokhin A, Luke JJ, Otero J, Nardi L, Singh A, Xyrafas A, Chen X, Mataraza J, Bedard PL. First-in-human phase I/Ib open-label dose-escalation study of GWN323 (anti-GITR) as a single agent and in combination with spartalizumab (anti-PD-1) in patients with advanced solid tumors and lymphomas. J Immunother Cancer. 2021 Aug;9(8):e002863. doi: 10.1136/jitc-2021-002863. |
| Label | URL |
|---|---|
| Study Results | View source |
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|
| Serum concentration profiles of GWN323 as a single agent: Cmax |
| 36 months |
| Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: Cmax | 36 months |
| Presence and titer of anti-GWN323 antibodies | 36 months |
| Measurement of the effector/regulatory T cell ratio | at screening, 36 months |
| Serum concentration profiles of GWN323 as a single agent: AUC | 36 months |
| Serum concentration profiles of GWN323 in combination with PDR001 and derived PK parameters: AUC | 36 months |
| Presence and titer of anti-PDR001 antibodies | 36 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Novartis Investigative Site | New York | New York | 10017 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Kashiwa | Chiba | 277 8577 | Japan |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
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