NCT05393466

BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase I/II, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xcovery Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.

Detailed description

This is a Phase I/II, open-label, non-randomized study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BPI-361175 tablets in patients with advanced NSCLC with EGFR C797S mutation and other EGFR-related mutations. Adult patients (18 and above) will receive a single dose of BPI-361175 followed by a 7-day washout period with continuous oral dosing of BPI-361175 in 28 days cycle. This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and pivotal Phase II study. It is expected to provide a brand-new treatment for advanced NSCLC. The study design utilizes a Bayesian Optimal Interval (BOIN) method to guide the dose level assignment of BPI-361175 and estimate the MTD/RP2D based on cumulative information on DLTs in the Cycle 0 + Cycle 1 of treatment.

Conditions

• Non-small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	BPI-361175	BPI-361175 is an oral fourth-generation EGFR inhibitor. The activation of EGFR signaling pathways is associated with various biological events such as proliferation, migration, differentiation, and apoptosis.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-01-30
• Completion: 2029-05-31
• First posted: 2022-05-26
• Last updated: 2025-10-07

Regulatory

• FDA-regulated drug study