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New treatment option for EGFR Mutation-positive NSCLC
Official title Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
ClinicalTrials.gov ID: NCT07500987
What this study is testing
What is [111In]-FPI-2107?
[111In]-FPI-2107 is an investigational medicine, being studied as a potential treatment for egfr mutation-positive nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join 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.
You likely can't join if
- Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shandong, China
- Wuhan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shandong, China; Wuhan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.