drugset / Trial / NCT06362980

A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations

NCT06362980

Phase 1 Recruiting 20 enrolled National Cancer Center, China
NaSingle-groupOpen-labelTreatment

Summary

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.

Timeline

Start
2024-05-22
Primary completion
2025-04-01
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BPI-1178 Unknown 200 mg Oral
Subject BPI-1178 Unknown 300 mg Oral
Subject Osimertinib Small molecule 80 mg Oral