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

RECRUITINGEARLY_PHASE1

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

NCT07229768•Yan Xing

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria:
•1. Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy;
•2. Patients with HER2-positive advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of HER2-targeted therapy;
•3. Patients with HR/HER2-negative advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of systemic therapy;
•4. Patients with advanced or metastatic high-grade soft tissue sarcoma (excluding chordoma) who have progressed after or are intolerant to at least 1 line of systemic therapy;
•5. Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy.
•2: Age \>= 18 years, regardless of sex;
•3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures;
•4: ECOG performance status score of 0 or 1;
•5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT;
+8 more criteria

Exclusion Criteria

•1: Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening
•2: Severe allergy to contrast agents or claustrophobia
•3: Expected survival period \< 6 months
•4: Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria
•5: Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose
•6: Participation in other clinical trials involving investigational drugs or devices within 4 weeks before the first dose
•7: Major surgery within 4 weeks before the first dose or planned major surgery during the study period
•8: Active bacterial, fungal, viral, or other infections requiring intravenous medication within 4 weeks before the first dose
•9: Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose
•10: History of other malignancies within 5 years before the first dose
+4 more criteria

Locations (1)

Shanghai General Hospital

Shanghai, China

Key Dates

Start Date

October 15, 2025

Primary Completion Date

November 30, 2026

Completion Date

December 31, 2026

Last Updated

November 17, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

177Lu-CTR-FAPI

DRUG

Contacts

Yan Xing

CONTACT

+86 21-36126600 xy.1@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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