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177Lu-JH04 in Patients with FAP-Positive Tumors

RECRUITINGEarly 1Sponsored by First Affiliated Hospital of Fujian Medical University
Actively Recruiting
PhaseEarly 1
SponsorFirst Affiliated Hospital of Fujian Medical University
Started2024-08-21
Est. completion2025-08-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06636617

Summary

This is a pilot study to assess the dosimetry, toxicity and response of 177Lu-JH04, a new FAP-targeted radiopharmaceutical, in patients with FAP-Positive Tumors. All patients underwent 68Ga-FAPI PET/CT for selection and were successively divided into three groups of 3 people each.The three groups received successively an approximately 3.70 GBq (100 mCi), 5.55 GBq (150 mCi) and 7.40 GBq (200 mCi) of 177Lu-JH04 up to 4 cycles.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* progressive advanced metastatic tumors
* tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT
* adequate renal, haematological, and liver function
* an Eastern Cooperative Oncology Group performance status of 0-2

Exclusion Criteria:

* pregnant or lactating women
* received other radionuclide therapy in the past 6 months
* received chemotherapy, radiotherapy and other anti-tumor treatments in the past 28 days

Conditions2

CancerPatients with Advanced Metastatic FAP-Positive Tumors

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