A Phase 1 interventional study of 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq in Patients With Advanced Metastatic FAP-Positive Tumors, sponsored by First Affiliated Hospital of Fujian Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by First Affiliated Hospital of Fujian Medical University · Phase 1, Interventional, and Treatment
This first-in-human study aimed to assess the safety and internal radiation dosimetry of 177Lu-JH040182, a novel FAP-targeted radiopharmaceutical, in patients with FAP-positive tumors. All patients underwent screening via 68Ga-FAPI PET/CT. Those confirmed to have FAP-positive lesions on PET imaging received administration of 177Lu-JH040182, and serial-time-point SPECT images were acquired for internal radiation dosimetry calculations.
Cancer-associated fibroblasts (CAFs) constitute a critical component of the tumor microenvironment and are widely distributed in the stroma of various malignancies. Fibroblast activation protein (FAP), a specific biomarker of CAFs, is overexpressed in more than 90% of malignant tumors but exhibits limited expression in normal tissues, rendering it an ideal target for the diagnosis and treatment of multiple cancers. To date, a variety of FAP-targeted radiopharmaceuticals have been developed for radionuclide therapy, such as 177Lu-FAPI-46 and 177Lu-FAP-2286. These agents have demonstrated potent anti-tumor efficacy and a favorable toxicity profile in oncological treatment. The novel radiopharmaceutical 177Lu-JH040182 also exhibits excellent in vitro and in vivo stability. Preclinical investigations have validated its high binding affinity, favorable safety profile and outstanding tumor selectivity, enabling specific accumulation within neoplastic tissues.
This study aimed to evaluate the dosimetric effects, toxicities and therapeutic efficacy of 177Lu-JH040182 in patients with advanced metastatic cancers who failed all prior therapeutic regimens without meaningful clinical improvement. Eligible patients first underwent 68Ga-FAPI PET/CT to confirm FAP-positive lesions (defined as >50% of lesions with an SUVmax exceeding 10). Upon confirmation, patients received intravenous administration of 177Lu-JH040182 at a radioactivity dose ranging from 5.55 to 7.40 GBq. Serial SPECT imaging was subsequently performed at multiple time points for each subject, and the absorbed doses to tumor lesions and normal physiological organs were quantified using the Hermes system software.
First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
It is planned to recruit 3 subjects with FAP-positive tumors for administration of 177Lu-JH040182 at a dose ranging from 5.55 to 7.50 GBq.
Drug: 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq
Subjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50 GBq.
Toxic and side effect
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
Dosimetry of normal organs and tumors
After the initial administration of 177Lu-JH040182, SPECT images will be acquired at multiple time points. The Hermes system will be used to calculate and record the absorbed doses of normal organs and tumors.
Time frame: through study completion, an average of 4 weeks
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Fujian Medical University