NCT07500987

Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC

A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of \[111In\]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.

Conditions

• EGFR Mutation-positive NSCLC

Interventions

Type	Name	Description
DRUG	[111In]-FPI-2107	radioimmuno-SPECT agent
DRUG	FPI-2053	unconjugated/unlabelled bispecific antibody \[cold\]

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-07-21
• Completion: 2026-07-21
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study