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NOT YET RECRUITING
NCT07639970
EARLY_PHASE1

Evaluation of [⁶⁸Ga/¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid Tumors

Sponsor: Hua Pang

View on ClinicalTrials.gov

Summary

Urokinase plasminogen activator receptor (uPAR), the cell-surface receptor for its ligand uPA, plays a critical role in regulating cell migration and invasion-key drivers of cancer progression. This study aims to evaluate a novel uPAR-targeting radiopharmaceutical pair: the diagnostic agent \[⁶⁸Ga\]Ga-HT547 and the therapeutic agent \[¹⁷⁷Lu\]Lu-HT547. In patients with breast cancer, head and neck cancer, pancreatic cancer, or glioma, we will assess the diagnostic performance and biodistribution of these tracers using \[⁶⁸Ga\]Ga-HT547 and \[¹⁷⁷Lu\]Lu-HT547 SPECT/CT.

Official title: Evaluation of the Safety, Biodistribution and Human Dosimetry of [68Ga]Ga-HT547 PET/CT and [177Lu]Lu-HT547 SPECT/CT in the Clinical Diagnosis of Solid Tumor Patients

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2027-10

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

[⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547

All enrolled participants will undergo the same intervention procedure: first, a single intravenous dose (approximately 150 MBq) of ⁶⁸Ga-HT547 for uPAR-targeted PET/CT diagnostic imaging. Subsequently, a single intravenous dose (approximately 4 GBq) of ¹⁷⁷Lu-HT547 will be administered for follow-up SPECT/CT imaging and dosimetry studies.