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

NCT07500987 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D8650C00002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

EGFR mutation-positive NSCLC; [111In]-FPI-2107; FPI-2053

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Tumour uptake of [111In]-FPI-2107

  During the Imaging period (Day1 - Day4/5)

• PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax)

  From the dose of investigation product (Day 1) until Day 4/5

• PK of [111In]-FPI-2107: AUClast

  From the dose of investigation product (Day 1) until Day 4/5

• PK of [111In]-FPI-2107: Clearance

  From the dose of investigation product (Day 1) until Day 4/5

• PK of [111In]-FPI-2107: Half-life

  From the dose of investigation product (Day 1) until Day 4/5

Study Arms (1)

[111In]-FPI-2107 and FPI-2053

EXPERIMENTAL

2 study interventions both based on the same EGFR and c-MET bispecific antibody

Drug: [111In]-FPI-2107; Drug: FPI-2053

Interventions

[111In]-FPI-2107 DRUG

radioimmuno-SPECT agent

[111In]-FPI-2107 and FPI-2053

FPI-2053 DRUG

unconjugated/unlabelled bispecific antibody \[cold\]

[111In]-FPI-2107 and FPI-2053

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Beijing, 100142, China

RECRUITING

Research Site

Shandong, China

RECRUITING

Research Site

Wuhan, 430022, China

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 30, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): July 21, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CN (3)