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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced metastatic solid tumors | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radionuclide therapy with [177Lu]Lu--TEFAPI-06 | Drug | A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0 | Safety and tolerability will be assessed by recording the frequency, duration, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs). The assessment includes clinically significant changes in vital signs (blood pressure, heart rate, respiratory rate, temperature), physical examination findings, 12-lead Electrocardiogram (ECG) parameters, and clinical laboratory tests (including Complete Blood Count [CBC], Urinalysis, Liver Function Tests [LFTs], and Renal Function Tests). Severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | From Baseline up to 30 days after the last dose of study intervention (approximately 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in [18F]-FAPI PET/CT Parameters in Target Lesions | [18F]-FAPI PET/CT images will be acquired to evaluate the expression of FAP within the tumor stroma. The efficacy assessment will be based on the quantitative analysis of Standardized Uptake Values (SUVmax and SUVmean) and Tumor-to-Background Ratios (TBR) of the target lesions. Changes in tracer uptake between the baseline scan and the follow-up scan will be calculated. |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution and Pharmacokinetics of [177Lu]Lu-TEFAPI-06 | Biodistribution will be assessed by quantitative analysis of Whole-Body planar and SPECT/CT images. Tracer uptake in blood, normal organs (kidneys, liver, etc.), and tumor tissues will be quantified at serial time points. Parameters to be analyzed include the percentage of injected dose (%ID) and percentage of injected dose per gram (%ID/g) for each regions of Interest (ROI) . |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital & Clinical Medical School, Lanzhou University | Lanzhou | Gansu | 730000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 | Dec 9, 2025 | Prot_SAP_000.pdf |
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| Baseline (Day 0) and 1 month post-treatment. |
| Change from Baseline in Tumor-Specific Serum Marker Levels | Peripheral blood samples will be collected to measure the serum concentration of tumor-specific biomarkers relevant to the indication (e.g., CEA, CA19-9, PSA, or other applicable markers). The change in concentration levels will be assessed to evaluate biochemical response. | Baseline (Day 0) and 1 month post-treatment. |
| 0.5, 2, 24, 48, 72, and 120 hours post-injection. |
| Radiation Absorbed Doses in Normal Organs and Tumor Lesions | Radiation dosimetry will be calculated based on biodistribution data derived from serial imaging. Following the administration of [177Lu]Lu-TEFAPI-06, Whole-Body (WB) planar scintigraphy and SPECT/CT scans will be performed. ROIs will be drawn over source organs and tumor lesions to generate time-activity curves. Absorbed doses (in Gy/GBq) will be estimated using standard dosimetry software (e.g., OLINDA/EXM or IDAC) based on the MIRD scheme. | Post-injection at 0.5, 2, 24, 48, 72, and 120 hours. |