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First-in-Human trial launches for targeted radiation therapy against FAP-Expressing tumors

NCT ID NCT07681141

Disease control Sponsor: First Affiliated Hospital of Fujian Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests a new radioactive drug called 177Lu-JH040182 in people with advanced cancers that have a protein called FAP on their cells. The drug is designed to deliver radiation directly to the tumor. The main goals are to check safety and measure how much radiation reaches the tumors and healthy organs. Only three people will take part, making this an early step in exploring whether this treatment could be developed further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
177Lu-JH040182 (a radioactive drug that targets FAP on tumor cells)
What this could lead to
If safe and effective, this approach could offer a new treatment option for patients with advanced cancers that express FAP.
What could go wrong
This is a very early, small study (3 people) focused on safety and dosing, not on curing the cancer. The drug may cause side effects or not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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

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Conditions

The condition(s) this trial relates to.

metastatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patients with advanced metastatic fap-positive tumors

Contacts and locations

Locations

  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China