Clinical trial NCT06636617: 177Lu-JH04 in Patients with FAP-Positive Tumors
Official title: Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Patients with Advanced Metastatic FAP-Positive Tumors
Keywords: Lu-177
FAP
Tumor
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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\&amp; 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.

Eligibility criteria: 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

Primary outcomes:
measure: Toxic and side effect
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
measure: Dosimetry of normal organs and tumors
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
measure: Treatment Response
timeFrame: through study completion, an average of 3 months
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital, Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: