177Lu-CTR-FAPI treatment for advanced, metastatic pancreatic cancer

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

This single-center, open-label study will try a radioligand called 177Lu-CTR-FAPI in people with advanced or metastatic pancreatic cancer (and other solid tumors) who have run out of standard treatment options.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07229768 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm, open-label Early Phase 1 trial administering 177Lu-CTR-FAPI to patients with unresectable, advanced, or metastatic solid tumors, with emphasis on pancreatic cancer. The study will monitor safety, measure radiation dosimetry, and record anti-tumor activity using RECIST 1.1 criteria. Eligible patients must have histologically or cytologically confirmed disease and have exhausted or declined standard therapies; certain breast cancer and high-grade soft tissue sarcoma subtypes are also eligible under specific prior-treatment requirements. Treatments and follow-up visits are performed at Shanghai General Hospital with imaging and clinical assessments to track response and adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable, advanced, or metastatic solid tumors—especially pancreatic cancer—who have confirmed disease and have progressed on or cannot tolerate standard treatments.

Not a fit: Patients with early-stage disease, those who still have effective standard treatment options, or tumors that do not express the FAP target may be unlikely to benefit.

Why it matters

Potential benefit: If successful, the treatment could shrink or slow growth of tumors by delivering targeted radiation, offering a new option for patients who have no standard therapies left.

How similar studies have performed: Early case reports and small Phase 1/2 work with 177Lu- or other radiolabeled FAPI agents have shown promising signals of tumor control, but robust evidence is still limited.

Eligibility criteria

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;
* 6: Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available);
* 7: At least 1 measurable lesion according to RECIST 1.1 criteria;
* 8: Previous anti-tumor toxicities recovered to grade 0-1;
* 9: Organ function meets requirements before first administration;

  1. Hematology: Absolute neutrophil count (ANC) \>= 1.5×10\^9/L; Hemoglobin (Hb) \>= 80 g/L; Platelet count (PLT) \>= 75×10\^9/L;
  2. Liver function: Total bilirubin (TB) \<= 1.5×ULN; AST and ALT \<= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST \<= 5×ULN;
  3. Renal function: Creatinine clearance \>= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF \<= 470 ms;
* 10: Fertile subjects voluntarily use effective contraception during treatment and for 4 months (male) or 7 months (female) after the last dose of study drug.

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
* 11: Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes
* 12: Presence of pleural effusion or ascites requiring treatment or judged by the investigator as uncontrolled at screening
* 13: Females who are pregnant or breastfeeding
* 14: Subjects considered by the investigator to have poor compliance and inability to cooperate with treatment and follow-up at screening.

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yan Xing

Conditions Pancreatic Cancer