Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
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.