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

NCT07299253 | Completed Early Phase 1

• 1 other identifier: 2023A-371
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Solid Tumors (Any Localization)

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Change from Baseline in [18F]-FAPI PET/CT Parameters in Target Lesions

  Baseline (Day 0) and 1 month post-treatment.

• Change from Baseline in Tumor-Specific Serum Marker Levels

  Baseline (Day 0) and 1 month post-treatment.

Other Outcomes (2)

• Biodistribution and Pharmacokinetics of [177Lu]Lu-TEFAPI-06

  0.5, 2, 24, 48, 72, and 120 hours post-injection.

• Radiation Absorbed Doses in Normal Organs and Tumor Lesions

  Post-injection at 0.5, 2, 24, 48, 72, and 120 hours.

Study Arms (1)

Patients with advanced metastatic solid tumors

EXPERIMENTAL

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

Interventions

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

A Novel Albumin-Binding FAPI Radiopharmaceutical for Theranostics

Patients with advanced metastatic solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

The Second Hospital & Clinical Medical School, Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Nuclear Medicine Department of the Second Hospital of Lanzhou University

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 23, 2025
• Study Start: August 16, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)