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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03829436 | TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers | PHASE1 | COMPLETED | 38 | — | — | Mar 20, 2019 | Sep 7, 2022 | Jul 3, 2023 | 11 | United States |
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
| Arm | Type | Description |
|---|---|---|
| Part 1 TPST-1120 | EXPERIMENTAL | Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression |
| Part 2 TPST-1120 + nivolumab | EXPERIMENTAL | Subjects will receive escalating doses of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression. |
| Part 3 TPST-1120 | EXPERIMENTAL | Selected dose of TPST-1120 administered orally twice daily until disease progression |
| Part 4 TPST-1120 + nivolumab | EXPERIMENTAL | Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression |
| Name | Type | Description |
|---|---|---|
| Part 1 TPST-1120 | DRUG | Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression |
| Part 2 TPST-1120 + nivolumab | DRUG | Subjects will receive escalating doses of TPST-1120 administered orally twice daily |
| Part 3 TPST-1120 | DRUG | Selected dose of TPST-1120 administered orally twice daily until disease progression |
| Part 4 TPST-1120 + nivolumab | DRUG | Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression |
Inclusion Criteria * Eastern Cooperative Oncology Group performance status of 0-1 at enrollment * Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible * Have at least one measurable lesion according to REC...