drugset / Trial / NCT05329298

A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors

NCT05329298 ↗

Phase 1/2 Unknown 90 enrolled Betta Pharmaceuticals Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.

Timeline

Start
2021-07-21
Primary completion
2023-06-30
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BPI-361175 Unknown — Oral