Recruiting NCT07500987
Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [111In]-FPI-2107, FPI-2053.
- Who it may be relevant to
- Registry conditions: EGFR Mutation-positive NSCLC. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug [111In]-FPI-2107
radioimmuno-SPECT agent - Drug FPI-2053
unconjugated/unlabelled bispecific antibody \[cold\]
Primary outcome measures
- Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053 [Time frame: From the screening period to 21 days after dosing]
- Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053 [Time frame: During the Imaging period (Day1 - Day4/5)]
- Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053 [Time frame: During the Imaging period (Day1 - Day4/5)]
Secondary outcome measures (5)
- Tumour uptake of [111In]-FPI-2107 [Time frame: During the Imaging period (Day1 - Day4/5)]
- PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax) [Time frame: From the dose of investigation product (Day 1) until Day 4/5]
- PK of [111In]-FPI-2107: AUClast [Time frame: From the dose of investigation product (Day 1) until Day 4/5]
- PK of [111In]-FPI-2107: Clearance [Time frame: From the dose of investigation product (Day 1) until Day 4/5]
- PK of [111In]-FPI-2107: Half-life [Time frame: From the dose of investigation product (Day 1) until Day 4/5]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 3 centers
- Research Site — Beijing
- Research Site — Shandong
- Research Site — Wuhan
Identifiers
NCT: NCT07500987 · D8650C00002