NCT05920135

First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Bridge Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207. It will consist of 3 parts; dose escalation, recommended phase 2 dose selection, and dose expansion.

Conditions

• EGFR Mutant Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BBT-207	BBT-207 given orally alone

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-08-01
• Completion: 2028-08-01
• First posted: 2023-06-27
• Last updated: 2025-04-27

Locations

3 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study