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Also known as TRX518
TRX518 monotherapy · 2 trials · 2 indications
Any adverse change in health or side effect from the initiation of the study drug dose TRX518 monotherapy and TRX518 in combination with gemcitabine, pembrolizumab or nivolumab through completion or premature withdrawal
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal
Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal
| Arm | Type | Description |
|---|---|---|
| TRX518 monotherapy (Parts A and B) | EXPERIMENTAL | Subjects receive an assigned dose of TRX518 administered intravenously one time per week or one time per cycle on a 21-day cycle |
| TRX518 with gemcitabine (Part C) | EXPERIMENTAL | Subjects receive an assigned dose of TRX518 (dosed one time per cycle) intravenously administered in combination with gemcitabine (dosed two times per cycle) on a 21-day cycle |
| TRX518 with pembrolizumab (Part D | EXPERIMENTAL | Subjects receive an assigned dose of TRX518 (dosed one time per cycle) intravenously administered in combination with pembrolizumab (dosed one time per cycle) on a 21-day cycle |
| TRX518 with nivolumab (Part E) | EXPERIMENTAL | Subjects receive an assigned dose of TRX518 (dosed two times per cycle) intravenously administered in combination with nivolumab (dosed two times per cycle) on a 28-day cycle |
| TRX518 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TRX518 monotherapy | DRUG | comparison of different (ascending) doses of TRX518 monotherapy |
| TRX518 with gemcitabine | DRUG | comparison of different (ascending) doses of TRX518 in combination with gemcitabine |
| TRX518 with pembrolizumab | DRUG | comparison of different (ascending) doses of TRX518 in combination with pembrolizumab |
| TRX518 with nivolumab | DRUG | comparison of different (ascending) doses of TRX518 in combination with nivolumab |
| TRX518 | BIOLOGICAL | Humanized, Fc disabled, anti-human GITR (glucocorticoid-induced tumor necrosis factor receptor) monoclonal antibody |
Inclusion Criteria: * Advanced Solid Malignancies: Histologically documented metastatic or locally advanced, incurable solid malignancy (Parts A and B); histologically documented metastatic or locally advanced, incurable solid malignancy for which gemcitabine is clinically appropriate (e.g., non-sm...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TRX518 is an investigational cancer therapy studied in adults with solid tumors, including unresectable Stage III or Stage IV malignant melanoma and other solid tumor malignancies. It has been evaluated as a monotherapy and in combination with gemcitabine, pembrolizumab, or nivolumab in Phase 1 clinical research.
TRX518 is being developed by Cypherpunk Technologies Inc., which trades under the ticker CYPH. The company has sponsored Phase 1 clinical research of TRX518 in patients with advanced solid tumors, including melanoma, in the United States.
TRX518 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 studies have been completed, including NCT02628574, which enrolled 109 patients, and NCT01239134, which enrolled 10 patients.
TRX518 has been studied in two completed Phase 1 trials. NCT02628574 evaluated TRX518 monotherapy and TRX518 combined with gemcitabine, pembrolizumab, or nivolumab in 109 patients with solid tumors. NCT01239134 evaluated TRX518 in 10 patients with Stage III or Stage IV malignant melanoma or other solid tumors.
Yes, TRX518 monotherapy refers to TRX518 given as a single agent, without combination therapy. The same drug has also been studied in combination with gemcitabine, pembrolizumab, or nivolumab in the Phase 1 trial NCT02628574.