EGFR Mutation-positive NSCLCPhase 1NCT07500987
Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC
A Phase 1 study testing [111In]-FPI-2107 and FPI-2053 in people with EGFR Mutation-positive NSCLC, run by AstraZeneca at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- EGFR Mutation-positive NSCLC
- What is being tested?
- [111In]-FPI-2107 and FPI-2053
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesChina
- Study dates
- 27 Feb 2026to 13 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Research Site
Beijing, 100142
Research Site
Shandong
Research Site
Wuhan, 430022
About this study
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
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
- Being tested
- [111In]-FPI-2107, FPI-2053
- Keywords
- EGFR mutation-positive NSCLC, [111In]-FPI-2107, FPI-2053
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[111In]-FPI-2107Drug
radioimmuno-SPECT agent
FPI-2053Drug
unconjugated/unlabelled bispecific antibody [cold]
| Study group | Role | What they receive |
|---|---|---|
| [111In]-FPI-2107 and FPI-2053 | Experimental | 2 study interventions both based on the same EGFR and c-MET bispecific antibody Receives: Drug: [111In]-FPI-2107; Drug: FPI-2053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: During the Imaging period (Day1 - Day4/5)
Secondary outcomes (5)
Tumour uptake of [111In]-FPI-2107
Tumour uptake of [111In]-FPI 2107 in selected regions of interest on SPECT/CT and/or planar images
Measured: During the Imaging period (Day1 - Day4/5)
PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax)
Determine the peak plasma concentration of [111In]-FPI-2107 following administration of FPI-2053 and [111In]-FPI-2107
Measured: From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: AUClast
Calculate the area under the curve using PK concentrations of [111In]-FPI-2107 to determine exposure of the product
Measured: From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Clearance
Determine the clearance of [111In]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of [111In]-FPI-2107
Measured: From the dose of investigation product (Day 1) until Day 4/5
PK of [111In]-FPI-2107: Half-life
Determine the half-life of [111In]-FPI-2107 with the pre-dose administration of FPI-2053 using PK concentrations of [111In]-FPI-2107
Measured: From the dose of investigation product (Day 1) until Day 4/5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start27 Feb 2026
- Primary completion13 May 2026
- Study completion13 May 2026
Why it stopped: Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation-positive NSCLCStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500987
- Sponsor's protocol ID
- D8650C00002
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07500987
- Acronym / sponsor ID
- D8650C00002
- Conditions
- EGFR Mutation-positive NSCLC
- Keywords
- EGFR mutation-positive NSCLC, [111In]-FPI-2107, FPI-2053
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [111In]-FPI-2107 and FPI-2053 | Experimental | Drug: [111In]-FPI-2107, Drug: FPI-20532 study interventions both based on the same EGFR and c-MET bispecific antibody |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [111In]-FPI-2107radioimmuno-SPECT agent | Drug | [111In]-FPI-2107 and FPI-2053 |
| FPI-2053unconjugated/unlabelled bispecific antibody [cold] | Drug | [111In]-FPI-2107 and FPI-2053 |
Primary outcome
Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053
Time frame: 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
Time frame: During the Imaging period (Day1 - Day4/5)
Residence time of the segmented source organs
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053
Time frame: During the Imaging period (Day1 - Day4/5)
Absorbed radiation doses of all target organs
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [111In]-FPI-2107 and FPI-2053 in people with EGFR Mutation-positive NSCLC, run by AstraZeneca at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053 (time frame: From the screening period to 21 days after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.