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

NCT07229768 | Recruiting Early Phase 1

• 1 other identifier: IIT2025-139
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• AE

  Adeverse Events

  From enrolment to 12 months after the first dose

Secondary Outcomes (2)

• Radiation Dosimetry

  one week after first dose

• ORR

  From first dose to 12 months afer

Study Arms (1)

177Lu-CTR-FAPI Treatment Arm

EXPERIMENTAL

Drug: 177Lu-CTR-FAPI

Interventions

177Lu-CTR-FAPI DRUG

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.

177Lu-CTR-FAPI Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : 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:
• Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy;
• 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;
• 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;
• 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;
• Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy.
• : Age \>= 18 years, regardless of sex;
• : Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures;
• : ECOG performance status score of 0 or 1;
• : FAP expression in tumor lesions confirmed positive by FAPI PET/CT;
• : Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available);
• : At least 1 measurable lesion according to RECIST 1.1 criteria;
• : Previous anti-tumor toxicities recovered to grade 0-1;
• : Organ function meets requirements before first administration;
• Hematology: Absolute neutrophil count (ANC) \>= 1.5×10\^9/L; Hemoglobin (Hb) \>= 80 g/L; Platelet count (PLT) \>= 75×10\^9/L;

You may not qualify if:

• : Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening
• : Severe allergy to contrast agents or claustrophobia
• : Expected survival period \< 6 months
• : Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria
• : Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose
• : Participation in other clinical trials involving investigational drugs or devices within 4 weeks before the first dose
• : Major surgery within 4 weeks before the first dose or planned major surgery during the study period
• : Active bacterial, fungal, viral, or other infections requiring intravenous medication within 4 weeks before the first dose
• : Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose
• : History of other malignancies within 5 years before the first dose
• : Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes
• : Presence of pleural effusion or ascites requiring treatment or judged by the investigator as uncontrolled at screening
• : Females who are pregnant or breastfeeding
• : Subjects considered by the investigator to have poor compliance and inability to cooperate with treatment and follow-up at screening.

Sponsors & Collaborators

• Yan Xing: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yan Xing

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 17, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)