TumorPhase 1/2NCT07822347
Research on NI-FAPI-04 for the Treatment of Hypoxic and Fibroblast Activation Protein Related Tumors
A Phase 1/2 study testing Injection of 177Lu-NI-FAPI in people with Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor
- What is being tested?
- Injection of 177Lu-NI-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 30 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80 years old
- Obtain pathological results through surgery or biopsy
- Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria)
- Expected survival time greater than 6 months
- Baseline [68Ga] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions
- Informed consent and the ability to accept follow-up
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- Bone marrow reserve: neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L
- Liver function: AST/ALT ≤ 3 × ULN, or subjects with liver metastasis<5 × ULN; Albumin>3.0 g/dL; Total bilirubin ≤ 1.5 × ULN
- Renal function: creatinine clearance rate ≥ 50 mL/min
- Coagulation function: INR ≤ 1.5 (for patients who have not received warfarin treatment); Prothrombin time (PTT)<2 × ULN
Who cannot join
- Pregnant and lactating female patients
- Individuals who fear confinement or radiation
- Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks
- Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months
- Individuals who have experienced severe allergic reactions to the components of [177Lu] Lu-NI-FAPI-04 injection in the past
- Received any investigational medication within 28 days prior to the first dose, or participated in another clinical study at the same time (except for those who participated in observational, non interventional clinical studies, or are currently in the follow-up period of interventional clinical studies)
- Patients who are difficult to receive further diagnosis and treatment due to severe illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality
About this study
Official title: Exploratory Study of a Novel Dual Target Molecular Probe NI-FAPI-04 for Intra Irradiation Therapy of Hypoxic and Fibroblast Activation Protein Related Tumors
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
- Conditions
- Tumor
- Being tested
- Injection of 177Lu-NI-FAPI
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 177Lu-NI-FAPIDrug
Subjects were injected with 177Lu-NI-FAPI at 60mCi or 120mCi.
| Study group | Role | What they receive |
|---|---|---|
| NI-FAPI group | Experimental | Injection of [177Lu]Lu-NI-FAPI Receives: Drug: Injection of 177Lu-NI-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
According to CTCAE v5.0, the number of patients who experienced adverse events was counted
Measured: 6-8 weeks after administration
Secondary outcomes (3)
Visual analysis of PET images before and after treatment
Describe the location of the lesion
Measured: 6-8 weeks after administration
The size of the lesion before and after treatment
Measure the size of the lesion（cm）
Measured: 6-8 weeks after administration
The degree of uptake of the lesion before and after treatment
Semi-quantitative analysis of changes in lesion uptake (SUVmax) before and after treatment
Measured: 6-8 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Aug 2025
- Primary completion24 Jun 2026
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Zhu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822347
- Sponsor's protocol ID
- I-25PJ0466
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of a Novel Dual Target Molecular Probe NI-FAPI-04 for Intra Irradiation Therapy of Hypoxic and Fibroblast Activation Protein Related Tumors
- ClinicalTrials.gov ID
- NCT07822347
- Acronym / sponsor ID
- I-25PJ0466
- Conditions
- Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 16 Sep 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.
Exploring the therapeutic value of a novel dual target molecular probe NI-FAPI-04 PET/CT with hypoxia and fibroblast activation related proteins in fibroblast activation related tumors. This study will lay the foundation for the further application of NI-FAPI-04 in tumor therapy and achieve the integration of molecular targeted probes for diagnosis, treatment, and efficacy monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NI-FAPI group | Experimental | Drug: Injection of 177Lu-NI-FAPIInjection of [177Lu]Lu-NI-FAPI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age between 18-80 years old
- Obtain pathological results through surgery or biopsy
- Loss of surgical opportunity (distant metastasis, or unsuitability for surgery due to contraindications); The condition still progresses after conventional chemotherapy, radiotherapy, targeted drug therapy, and other treatments (according to RECIST/PERCAST criteria)
- Expected survival time greater than 6 months
- Baseline [68Ga] Ga-NI-FAPI-04 PET/CT imaging reveals high uptake lesions
Key exclusion criteria (7 listed)
- Pregnant and lactating female patients
- Individuals who fear confinement or radiation
- Individuals who have received systemic anti-tumor treatment, including chemotherapy or curative radiotherapy, within 4 weeks prior to their first medication, or who have received TKI treatment within 2 weeks
- Patients treated with isotopes such as strontium-89, samarium-153, rhenium 186, rhenium 188, radium-223, etc. within 6 months
- Individuals who have experienced severe allergic reactions to the components of [177Lu] Lu-NI-FAPI-04 injection in the past
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 |
|---|---|---|
| Injection of 177Lu-NI-FAPISubjects were injected with 177Lu-NI-FAPI at 60mCi or 120mCi. | Drug | NI-FAPI group |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 6-8 weeks after administration
According to CTCAE v5.0, the number of patients who experienced adverse events was counted
3 secondary outcomes
Visual analysis of PET images before and after treatment
Time frame: 6-8 weeks after administration
The size of the lesion before and after treatment
Time frame: 6-8 weeks after administration
The degree of uptake of the lesion before and after treatment
Time frame: 6-8 weeks after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Injection of 177Lu-NI-FAPI in people with Tumor, run by Peking Union Medical College Hospital at 1 site 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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 16 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 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 6-8 weeks after administration). 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 16 Sep 2026.