Calendario›TPST›TPST-1495 twice daily

TPST-1495 twice daily

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

Ensayo de Tempest Therapeutics, Inc. en Solid Tumor · Colorectal Cancer · Non Small Cell Lung Cancer · Squamous Cell Carcinoma of Head and Neck · Urothelial Carcinoma · Endometrial Cancer · Gastroesophageal Junction Adenocarcinoma · Gastric Adenocarcinoma · Solid Tumors With PIK3Ca Mutation (del registro, en inglés).

Más ensayos de: Tumor sólido · Cáncer colorrectal · Cáncer de pulmón no microcítico · Carcinoma escamoso de cabeza y cuello · Carcinoma urotelial · Cáncer de endometrio · Adenocarcinoma de la unión gastroesofágica · Adenocarcinoma gástrico.

Fase

Fase 1

Estado

Completado

Participantes

89

previstos

Centros

11

Fin del objetivo primario

sep 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2020.

Qué mide

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 (From start of treatment to treatment termination visit, up to 24 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a first-in-human Phase 1a/1b, multicenter, open-label, dose-escalation, dose and schedule optimization, and expansion study of TPST-1495 as a single agent and in combination with pembrolizumab to determine its maximum tolerated dose (MTD) and or recommended Phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity in subjects with advanced solid tumors. Subjects with all histologic types of solid tumors are eligible for the escalation and dose-finding portions of the study. However, the preferred tumor types for enrollment are colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, endometrial cancer, and gastroesophageal junction (GEJ) or gastric adenocarcinoma. Enrollment in the expansion cohorts is limited to the following tumor types: endometrial, SCCHN, CRC, and a basket cohort in subjects selected for an activating mutation in PIK3Ca.

Más ensayos de TPST

Todos los de TPST, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04344795), actualizada en sep 2025.