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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04344795 | Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors | PHASE1 | COMPLETED | 89 | — | — | May 6, 2020 | Sep 25, 2024 | Sep 12, 2025 | 11 | United States |
Determination of maximum tolerated dose and/or recommended Phase 2 dose (RP2D) and optimum dose schedule for TPST-1495 as a single agent and in combination with pembrolizumab based on dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| TPST-1495 monotherapy dose escalation | EXPERIMENTAL | Subjects will receive escalating doses of TPST-1495 administered orally twice daily until maximum tolerated dose is reached or until disease progression |
| TPST-1495 monotherapy dose and schedule optimization | EXPERIMENTAL | Subjects will receive alternative TPST-1495 administration schedules until RP2D for the selected schedule is determined or until disease progression. |
| TPST-1495 monotherapy dose expansion | EXPERIMENTAL | Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression |
| TPST-1495 in combination with pembrolizumab dose and schedule optimization | EXPERIMENTAL | Subjects will receive alternative TPST-1495 administration schedules in combination with pembrolizumab until RP2D for the selected schedule is determined or until disease progression. |
| TPST-1495 in combination with pembrolizumab dose expansion | EXPERIMENTAL | Subjects will receive selected dose regimen from dose and schedule optimization stage until disease progression |
| Name | Type | Description |
|---|---|---|
| TPST-1495 twice daily | DRUG | TPST-1495 administered orally twice daily |
| TPST-1495 once daily or on intermittent schedule | DRUG | TPST-1495 administered orally once daily or on intermittent schedule |
| Pembrolizumab | DRUG | Pembrolizumab dosed per label recommendations |
Subjects must meet all the following inclusion criteria to be eligible: 1. Subjects must have a histologically-confirmed malignancy that is metastatic or unresectable for which there is no remaining standard therapy known to confer clinical benefit. While all solid tumor types are eligible for the ...
| 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 |