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

NCT ID: NCT07299253

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-16

Study Completion Date

2025-08-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Metastatic Solid Tumors (Any Localization)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with advanced metastatic solid tumors

Group Type EXPERIMENTAL

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

Intervention Type DRUG

A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics

Interventions

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

A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lanzhou University Second Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiangyan Liu

Director of the Nuclear Medicine Department of the Second Hospital of Lanzhou University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2023A-371

Identifier Type: -

Identifier Source: org_study_id