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

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.

Study Overview

• Status: Recruiting
• Conditions: EGFR Mutation-positive NSCLC
• Intervention / Treatment: Drug: [111In]-FPI-2107; Drug: FPI-2053

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Research Site
  • Shandong, China
    • Recruiting
    • Research Site
  • Wuhan, China, 430022
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed EGFR mutation positive NSCLC.
• Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy.
• At least one lesion that is present on 18F-FDG PET/CT scan during screening.
• ECOG performance status of 0 or 1.
• Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator.
• Able to provide tumour tissue for analysis.

Exclusion Criteria:

• Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of [111In]-FPI-2107.
• Contraindications to or inability to perform the imaging procedures required in this study.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).
• History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of [111In]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension.
• Clinically relevant proteinuria, or daily urinary protein excretion > 500 mg).
• Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
• Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study.
• External beam radiation therapy within 28 days prior to the administration of [111In]-FPI-2107.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [111In]-FPI-2107 and FPI-2053; 2 study interventions both based on the same EGFR and c-MET bispecific antibody	Drug: [111In]-FPI-2107; radioimmuno-SPECT agent; Drug: FPI-2053; unconjugated/unlabelled bispecific antibody [cold]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053	Safety and tolerability will be evaluated by frequency, duration, and severity of AEs, and changes in clinical, laboratory, and ECG parameters compared to baseline	From the screening period to 21 days after dosing
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053	Residence time of the segmented source organs	During the Imaging period (Day1 - Day4/5)
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053	Absorbed radiation doses of all target organs	During the Imaging period (Day1 - Day4/5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumour uptake of [111In]-FPI-2107	Tumour uptake of [111In]-FPI 2107 in selected regions of interest on SPECT/CT and/or planar images	During the Imaging period (Day1 - Day4/5)
PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax)	Determine the peak plasma concentration of [111In]-FPI-2107 following administration of FPI-2053 and [111In]-FPI-2107	From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: AUClast	Calculate the area under the curve using PK concentrations of [111In]-FPI-2107 to determine exposure of the product	From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Clearance	Determine the clearance of [111In]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of [111In]-FPI-2107	From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Half-life	Determine the half-life of [111In]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of [111In]-FPI-2107	From the dose of investigation product (Day 1) until Day 4/5

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: EGFR mutation-positive NSCLC; FPI-2053; [111In]-FPI-2107
• Other Study ID Numbers: D8650C00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No