Recent Updates
Recently added Catalysts

-FPI-2107

Phase 1

EGFR Mutation-positive NSCLC | Small molecule | Other |AstraZeneca PLC|Last Updated: May 20, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07500987Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLCPHASE1 RECRUITING 12 — — Feb 27, 2026Jul 21, 2026May 20, 20263 China
Unlock Drug Trial Details
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
Unlock Study Endpoints
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 \[cold\]
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria