NCT06636617

177Lu-JH04 in Patients with FAP-Positive Tumors

Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cancer-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment and present abundantly in the stroma of multiple tumor entities. Fibroblast activation protein (FAP), as a specific marker protein of CAFs, is overexpressed on more than 90% of malignant tumors\& limited and expression in normal tissues, making it an appropriate target for diagnosis and therapy of numerous malignant tumors. Currently, several radiopharmaceuticals targeting FAP for radionuclide therapy have been developed, such as 177Lu-FAPI-46, 177Lu-FAP-2286, and showed high efficacy and reasonable toxicity profile in tumor treatment. 177Lu-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, we assess the dosimetry, toxicity and response of 177Lu-JH04 for the treatment of patients with advanced metastatic cancers after exhaustion of all other treatment options.

Conditions

• Patients with Advanced Metastatic FAP-Positive Tumors

Interventions

Type	Name	Description
DRUG	3.70 GBq (100 mCi) of 177Lu-JH04	All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.
DRUG	5.55 GBq (150 mCi) of 177Lu-JH04	All 3 patients were intravenous injected with single 5.55 GBq (150 mCi) of 177Lu-JH04
DRUG	7.40 GBq (200 mCi) of 177Lu-JH04	All 3 patients were intravenous injected with single 7.40 GBq (200 mCi) of 177Lu-JH04

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-10-10
• Last updated: 2024-10-10

Locations

1 site across 1 country: China