OncoMatch/Clinical Trials/NCT07229768
Clinical Study of 177Lu-CTR-FAPI In the Treatment of Patients With Advanced, Metastatic Solid Tumors
Is NCT07229768 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies 177Lu-CTR-FAPI for pancreatic cancer.
Treatment: 177Lu-CTR-FAPI — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: FAP overexpression (confirmed positive by FAPI PET/CT)
FAP expression in tumor lesions confirmed positive by FAPI PET/CT
Disease stage
Required: Stage IV
Metastatic disease required
Grade: high-grade
unresectable, advanced, or metastatic solid tumors; at least 1 measurable lesion according to RECIST 1.1 criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — disease-specific (see extraction_notes)
have failed standard treatment, lack standard treatment options, or refuse standard treatment
Cannot have received: systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.)
Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose
Cannot have received: systemic radionuclide therapy
Exception: excluding I-131 treatment for thyroid cancer
Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose
Cannot have received: external beam radiotherapy
Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1.5×10^9/L; Hemoglobin (Hb) >= 80 g/L; Platelet count (PLT) >= 75×10^9/L
Kidney function
Creatinine clearance >= 50 mL/min (Cockcroft-Gault formula)
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
Cardiac function
ECG: QTcF <= 470 ms
Organ function meets requirements before first administration; Hematology: ANC >= 1.5×10^9/L; Hb >= 80 g/L; PLT >= 75×10^9/L; Liver function: TB <= 1.5×ULN; AST and ALT <= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST <= 5×ULN; Renal function: Creatinine clearance >= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF <= 470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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