Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02628574 | Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab | PHASE1 | COMPLETED | 109 | — | — | Jan 1, 2016 | Jul 14, 2020 | Aug 3, 2025 | 6 | United States |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |