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FPI-2107

Phase 1

EGFR Mutation-positive NSCLC | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 17, 2026

Target and mechanism

ModalitySmall molecule

Also known as [111In]-FPI-2107

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

FPI-2107 · 1 trial · 1 indication

Phase 1 1
NCT07500987Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLCEGFR Mutation-positive NSCLC
RECRUITING12 Analytics
PHASE1RECRUITING
Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
EGFR Mutation-positive NSCLCUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053
From the screening period to 21 days after dosing

Safety and tolerability will be evaluated by frequency, duration, and severity of AEs, and changes in clinical, laboratory, and ECG parameters compared to baseline

Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053
During the Imaging period (Day1 - Day4/5)

Residence time of the segmented source organs

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[111In]-FPI-2107 and FPI-2053EXPERIMENTAL2 study interventions both based on the same EGFR and c-MET bispecific antibody

Interventions

NameTypeDescription
[111In]-FPI-2107DRUGradioimmuno-SPECT agent
FPI-2053DRUGunconjugated/unlabelled bispecific antibody \[cold\]
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites3

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. * A...

Countries:China
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Recent Changes (Last 90 Days)

LOWJun 18, 2026NCT07500987lastUpdatePostDate: changed
LOWJun 18, 2026NCT07500987lastUpdatePostDate: changed
LOWJun 18, 2026NCT07500987lastUpdatePostDate: changed
LOWJun 18, 2026NCT07500987lastUpdatePostDate: changed

Frequently asked questions about FPI-2107

What is FPI-2107 used for?

FPI-2107 is an investigational small molecule being developed for use in EGFR mutation-positive non-small cell lung cancer (NSCLC). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does FPI-2107 target?

FPI-2107 is being studied in patients with EGFR mutation-positive NSCLC, indicating it is designed to interact with the EGFR pathway. The specific molecular target of FPI-2107 has not been disclosed in available information.

Who makes FPI-2107?

FPI-2107 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is FPI-2107 in?

FPI-2107 is in Phase 1 clinical development. It is an investigational drug and has not received approval from regulatory authorities for any use.

What clinical trials is FPI-2107 in?

FPI-2107 is being evaluated in a Phase 1 clinical trial with the identifier NCT07500987. This study is recruiting participants with EGFR mutation-positive NSCLC in China and has an enrollment target of 12 patients.

Is FPI-2107 the same as [111In]-FPI-2107?

Yes, FPI-2107 is also known as [111In]-FPI-2107. The alternative name reflects the radiolabeled form of the compound, which is used in the clinical trial setting.