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

NCT07500987 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-05-20

No results posted yet for this study

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

DRUG

[111In]-FPI-2107

radioimmuno-SPECT agent

DRUG

FPI-2053

unconjugated/unlabelled bispecific antibody \[cold\]

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2026-07-21
Completion
2026-07-21
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07500987 on ClinicalTrials.gov