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

NCT07822347 | Enrolling By Invitation Phase 1

• 1 other identifier: I-25PJ0466
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor

Outcome Measures

Primary Outcomes (1)

• 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

  6-8 weeks after administration

Secondary Outcomes (3)

• Visual analysis of PET images before and after treatment

  6-8 weeks after administration

• The size of the lesion before and after treatment

  6-8 weeks after administration

• The degree of uptake of the lesion before and after treatment

  6-8 weeks after administration

Other Outcomes (1)

• Objective response rate of [177Lu] Lu-NI-FAPI-04

  6-8 weeks after administration

Study Arms (1)

NI-FAPI group

EXPERIMENTAL

Injection of \[177Lu\]Lu-NI-FAPI

Drug: Injection of 177Lu-NI-FAPI

Interventions

Injection of 177Lu-NI-FAPI DRUG

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

NI-FAPI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 16, 2026
• Study Start: August 15, 2025
• Primary Completion: June 24, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)