Patients With Advanced Metastatic FAP-Positive TumorsPhase 1NCT07681141
Clinical Study of 177Lu-JH040182 in Patients With FAP-Positive Malignancies
A Phase 1 study testing 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq in people with Patients With Advanced Metastatic FAP-Positive Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With Advanced Metastatic FAP-Positive Tumors
- What is being tested?
- 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- progressive advanced metastatic tumors
- tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
- an Eastern Cooperative Oncology Group performance status of 0-2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: First-in-Human Safety and Dosimetry Study of ¹⁷⁷Lu-FAPI in Patients With FAP-Positive Malignancies
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.
Read the detailed description
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.
- Being tested
- 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq
- Keywords
- fibroblast activation protein, lutetium-177
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-JH040182 with an activity of approximately 5.55-7.50 GBqDrug
Subjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50 GBq.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous administration of 177Lu-JH040182 | Experimental | 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. Receives: Drug: 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
Secondary outcomes (1)
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.
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Advanced Metastatic FAP-Positive TumorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, The First Affiliated Hospital, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681141
- Sponsor's protocol ID
- FirstAHFujian-177Lu-JH040182
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Safety and Dosimetry Study of ¹⁷⁷Lu-FAPI in Patients With FAP-Positive Malignancies
- ClinicalTrials.gov ID
- NCT07681141
- Acronym / sponsor ID
- FirstAHFujian-177Lu-JH040182
- Keywords
- fibroblast activation protein, lutetium-177
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous administration of 177Lu-JH040182 | Experimental | Drug: 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBqIt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- progressive advanced metastatic tumors
- tumors with high FAP expression confirmed on 68Ga-FAPI PET/CT (defined as a maximum standardized uptake value ≥10 in more than 50% of tumor lesions)
- an Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBqSubjects will receive intravenous administration of 177Lu-JH040182 at an activity of approximately 5.55-7.50 GBq. | Drug | Intravenous administration of 177Lu-JH040182 |
Primary outcome
Toxic and side effect
Time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
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.
1 secondary outcome
Dosimetry of normal organs and tumors
Time frame: through study completion, an average of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Related trials for Patients With Advanced Metastatic FAP-Positive Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Miao, MD principal investigator
The First Affiliated Hospital, Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-JH040182 with an activity of approximately 5.55-7.50 GBq in people with Patients With Advanced Metastatic FAP-Positive Tumors, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxic and side effect (time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.