RecruitingEarly Phase 1NCT07229768

Clinical Study of 177Lu-CTR-FAPI In the Treatment of Patients With Advanced, Metastatic Solid Tumors

A Single-Center, Single-Arm, Open-Label Clinical Study of 177Lu-CTR-FAPI Injection in the Treatment of Patients With Advanced, Metastatic Solid Tumors


Sponsor

Yan Xing

Enrollment

4 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, single-arm, open-label clinical study of 177Lu-CTR-FAPI injection in the treatment of patients with advanced, metastatic solid tumors i.e. pancreatic cancer, to assess safety, radio-dosimetry, and efficacy per RESIST 1.1.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of targeted radiation therapy called 177Lu-CTR-FAPI for people with advanced solid tumors that have spread and cannot be cured with standard treatments. This therapy uses a radioactive substance that seeks out cancer cells. **You may be eligible if...** - You have an advanced or metastatic solid tumor confirmed by biopsy - Standard treatments have failed, are not available, or you have declined them - Preferred tumor types include pancreatic cancer, triple-negative breast cancer, or soft tissue sarcoma - You have received at least 2 prior treatment lines for your cancer type - Your major organs are functioning adequately **You may NOT be eligible if...** - Your tumor has not been confirmed by biopsy or lab test - You have active, uncontrolled brain metastases - You have severe kidney or bone marrow problems - You are pregnant or breastfeeding - You have had recent major surgery or radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-CTR-FAPI

The medication is administered intravenously, with a single dose of 200 mCi (7.4 GBq) ±10%, administered once every 6 ± 2 weeks. The planned course consists of 4 doses, or until the radiation safety threshold for major organs is reached based on radiation dosimetry assessment.


Locations(1)

Shanghai General Hospital

Shanghai, China

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NCT07229768


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