Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRX518 monotherapy · 1 trial · 1 indication
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
| 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 |
| 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 |
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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TRX518 is an investigational monoclonal antibody being studied for the treatment of unresectable Stage III or Stage IV malignant melanoma and other solid tumor malignancies, as well as solid tumors. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
TRX518 is a monoclonal antibody designed to target GITR, a protein involved in immune regulation. By binding to GITR, TRX518 aims to modulate the immune system's response against tumor cells, potentially enhancing anti-tumor activity in patients with certain cancers.
TRX518 is being developed by Cypherpunk Technologies Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of TRX518 in patients with advanced melanoma and other solid tumors.
TRX518 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Clinical trials are ongoing to assess its safety, tolerability, and potential efficacy in treating certain types of cancer.
TRX518 has been studied in two completed Phase 1 clinical trials. The first trial, NCT01239134, evaluated TRX518 in patients with unresectable Stage III or Stage IV malignant melanoma or other solid tumors. The second trial, NCT02628574, assessed TRX518 as monotherapy and in combination with gemcitabine, pembrolizumab, or nivolumab in patients with solid tumors.
TRX518 is also known as anti-GITR mAb, as it is a monoclonal antibody that targets GITR. In clinical trial records, it is sometimes referred to by this descriptive name. Both names refer to the same investigational drug being developed by Cypherpunk Technologies Inc.