Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06

Lanzhou University Second Hospital

Status and phase: Completed; Early Phase 1

Conditions: Metastatic Solid Tumors (Any Localization)

Treatments: Drug: radionuclide therapy with [177Lu]Lu--TEFAPI-06

Study type: Interventional

Funder types: Other

Identifiers

NCT07299253

2023A-371

Details and patient eligibility

About

This study aims to systematically evaluate the safety, biodistribution, dosimetry, and preliminary therapeutic potential of [177Lu]Lu-TEFAPI-06 through an exploratory first-in-human (FIH) trial.

Full description

This study represents a comprehensive "bench-to-bedside" translational investigation, providing the first systematic report on the safety profile of [177Lu]Lu-TEFAPI-06-a novel albumin-binding fibroblast activation protein inhibitor (FAPI) radiopharmaceutical-and its successful transition into a FIH. The investigators preliminarily evaluated its safety, dosimetry, and therapeutic response in patients with ibroblast activation protein (FAP)-overexpressing metastatic solid tumors.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Histologically confirmed advanced metastatic solid tumors refractory or intolerant to standard therapies
• ECOG performance status 0-2
• Life expectancy > 3 months
• At least one FAP-avid lesion confirmed by baseline [18F]-FAPI PET/CT
• Adequate organ and bone marrow function prior to the first dose

Exclusion criteria

• Chemotherapy, radiotherapy, or targeted therapy within 4 weeks
• Severe hepatic or renal dysfunction
• Uncontrolled active infection or severe comorbidities

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Patients with advanced metastatic solid tumors

Experimental group

Treatment:

Drug: radionuclide therapy with [177Lu]Lu--TEFAPI-06