Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
Completed · Phase 1
Conditions studied: 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
In brief
This 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.
Key facts
- Study ID
- NCT04344795
- Run by
- Tempest Therapeutics
- People needed
- 89
- Starts
- 2020-05-06
- Expected to finish
- 2024-09-25
- Last updated by the study team
- 2025-09-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Colorado — Aurora, Colorado, United States
- Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine — Baltimore, Maryland, United States
- Baystate Gynecologic Oncology — Springfield, Massachusetts, United States
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
- START Midwest — Grand Rapids, Michigan, United States
- Carolina BioOncology Institute — Huntersville, North Carolina, United States
- SCRI-OK Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.