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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TPST-1495 is an investigational small molecule being studied in adults with advanced solid tumors. The Phase 1a/1b trial enrolled patients with colorectal cancer, non small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, endometrial cancer, gastric and gastroesophageal junction adenocarcinoma, and solid tumors with PIK3CA mutations.
TPST-1495 is in Phase 1 development. Its single registered trial, NCT04344795, was a Phase 1a/1b study that has been completed. The study enrolled 89 participants and evaluated TPST-1495 both as a single agent and in combination with pembrolizumab in patients with solid tumors.
TPST-1495 is being developed by Tempest Therapeutics, Inc., which trades on the Nasdaq under the ticker TPST. The company sponsored the Phase 1a/1b trial of the compound in solid tumors.
TPST-1495 has been evaluated in one registered clinical trial, NCT04344795, titled a Phase 1a/1b study of TPST-1495 as a single agent and in combination with pembrolizumab in subjects with solid tumors. The trial was conducted in the United States, enrolled 89 adults, and is now completed.
No. The Phase 1a/1b trial of TPST-1495, NCT04344795, was not randomized and was not double blind. It used a controlled design, enrolled 89 participants aged 18 years and older of any sex, and did not include healthy volunteers.
Yes. The Phase 1a/1b trial of TPST-1495, NCT04344795, included a biomarker selected population, enrolling patients with solid tumors carrying PIK3CA mutations alongside other advanced solid tumor types such as colorectal, non small cell lung, head and neck, urothelial, endometrial, and gastric cancers.