177Lu-JH04 in Patients with FAP-Positive Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3.70 GBq (100 mCi) of 177Lu-JH04, 5.55 GBq (150 mCi) of 177Lu-JH04, 7.40 GBq (200 mCi) of 177Lu-JH04.
- Who it may be relevant to
- Registry conditions: Patients with Advanced Metastatic FAP-Positive Tumors. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety, Dosimetry and Treatment Response of 177Lu-JH04 in Patients with FAP-Positive Tumors
Overview
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.
Interventions
- 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
Primary outcome measures
- Toxic and side effect [Time frame: through study completion, an average of 2 weeks]
Secondary outcome measures (1)
- Dosimetry of normal organs and tumors [Time frame: through study completion, an average of 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT06636617 · FirstAHFujian-177Lu-JH04