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Enrolling by invitation Phase 1/2

Research on NI-FAPI-04 for the Treatment of Hypoxic and Fibroblast Activation Protein Related Tumors

NCT07822347 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-08-15
Last updated
2026-09-16

Condition(s) studied

Tumor

Investigational drug(s) / intervention(s)

Injection of 177Lu-NI-FAPI

Injection of 177Lu-NI-FAPI: Subjects were injected with 177Lu-NI-FAPI at 60mCi or 120mCi.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 — 6-8 weeks after administration
    According to CTCAE v5.0, the number of patients who experienced adverse events was counted

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07822347 on ClinicalTrials.gov ↗ ← All trials in China