NCT06001671

Antitumor Activity and Safety of BEBT-109, a Novel EGFR Inhibitor, in Previously Treated NSCLC

Antitumor Activity and Safety of BEBT-109, a Novel EGFR Inhibitor, in Previously Treated NSCLC With EGFR Exon 20 Insertion Mutations: a Phase 1B, Dose Escalation and Expansion Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study was a first-in-human, phase 1B, single-center, single-arm, open-label, dose escalation and expansion trial that aimed to determine the safety, tolerability and efficacy of BEBT-109 in patients with locally advanced or metastatic NSCLC harboring EGFR exon20ins mutations who had received at least one line of previous treatment.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	BEBT-109	BEBT-109 is based on the "3+3" model, with a dose ascent starting from 120mg qd

Timeline

• Start date: 2020-10-27
• Primary completion: 2023-03-01
• Completion: 2023-08-08
• First posted: 2023-08-21
• Last updated: 2023-10-06

Locations

1 site across 1 country: China