177Lu-JH04 in Patients with FAP-Positive Tumors

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Patients with Advanced Metastatic FAP-Positive Tumors

Treatments: Drug: 5.55 GBq (150 mCi) of 177Lu-JH04; Drug: 7.40 GBq (200 mCi) of 177Lu-JH04; Drug: 3.70 GBq (100 mCi) of 177Lu-JH04

Study type: Interventional

Funder types: Other

Identifiers

NCT06636617

FirstAHFujian-177Lu-JH04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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9 participants in 3 patient groups

3.70 GBq (100 mCi) of 177Lu-JH04

Experimental group

Description:

All 3 patients were intravenous injected with single dose 3.70 GBq (100 mCi) of 177Lu-JH04.

Treatment:

Drug: 3.70 GBq (100 mCi) of 177Lu-JH04

5.55 GBq (150 mCi) of 177Lu-JH04

Experimental group

Description:

All 3 patients were intravenous injected with single dose 5.55 GBq (150 mCi) of 177Lu-JH04.

Treatment:

Drug: 5.55 GBq (150 mCi) of 177Lu-JH04

7.40 GBq (200 mCi) of 177Lu-JH04

Experimental group

Description:

All 3 patients were intravenous injected with single dose 7.40 GBq (200 mCi) of 177Lu-JH04.

Treatment:

Drug: 7.40 GBq (200 mCi) of 177Lu-JH04