RecruitingPhase 1NCT07500987

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

Sponsor

AstraZeneca

Enrollment

12 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

EGFR Mutation-positive NSCLC

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.

Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called FPI-2053 and a drug called [111In]-FPI-2107 for people with egfr mutation-positive nsclc. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 130 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[111In]-FPI-2107

radioimmuno-SPECT agent

DRUGFPI-2053

unconjugated/unlabelled bispecific antibody \[cold\]

Locations(3)

Research Site

Beijing, China

Research Site

Shandong, China

Research Site

Wuhan, China

View Full Details on ClinicalTrials.gov

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NCT07500987