Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TPST-1495 twice daily · 1 trial · 9 indications
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 |
| 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 |
TPST-1495 is an investigational small molecule being studied for the treatment of solid tumors, including colorectal cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, endometrial cancer, gastroesophageal junction adenocarcinoma, gastric adenocarcinoma, and solid tumors with PIK3Ca mutations. It is in Phase 1 clinical development.
TPST-1495 is being developed by Tempest Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol TPST. The company is conducting clinical trials of TPST-1495 in patients with solid tumors.
TPST-1495 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received orphan drug designation from the FDA for its intended use in solid tumors.
TPST-1495 is being studied in a Phase 1a/1b trial (NCT04344795) as a single agent and in combination with pembrolizumab in subjects with solid tumors. This trial has been completed and enrolled 89 participants in the United States.
Yes, TPST-1495 twice daily refers to the dosing regimen of TPST-1495, which is administered twice daily in clinical trials. The drug is being studied as a single agent and in combination with pembrolizumab for the treatment of solid tumors.