NCT05329298

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

A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BPI-361175	Subjects will receive BPI-361175 until disease progression

Timeline

• Start date: 2021-07-21
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2022-04-15
• Last updated: 2022-04-15

Locations

8 sites across 1 country: China