Preclinical Safety Evaluation and First-in-Human Translational Study of [177Lu]Lu-TEFAPI-06
NCT ID: NCT07299253
Last Updated: 2025-12-23
Study Results
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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COMPLETED
EARLY_PHASE1
5 participants
INTERVENTIONAL
2023-08-16
2025-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with advanced metastatic solid tumors
radionuclide therapy with [177Lu]Lu--TEFAPI-06
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe hepatic or renal dysfunction
* Uncontrolled active infection or severe comorbidities
18 Years
ALL
No
Sponsors
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Lanzhou University Second Hospital
OTHER
Responsible Party
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Jiangyan Liu
Director of the Nuclear Medicine Department of the Second Hospital of Lanzhou University
Locations
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The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2023A-371
Identifier Type: -
Identifier Source: org_study_id
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