Clinical Trial · NCT07639970

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

Overview

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.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Phase

Early Phase 1

Contacts

Hua Pang, Doctor (CONTACT)

phua1973@163.com

+8615923039337

ClinicalTrials.gov

NCT07639970

Drug / Compound

HT547

Isotope(s):

Target(s):

uPAR

HT547

Isotope(s):

Target(s):

uPAR

Eligibility

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
1. Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent.
Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.
Expected survival of at least 3 months.
Aged 18 years or older, regardless of gender.

Exclusion

Received any investigational drug within 28 days prior to the first dose, or concurrent participation in another clinical study (except: participation in an observational, non-interventional study, or being in the follow-up phase of an interventional study).
Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
1. Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.
Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.
History of severe allergic reaction to any component of the investigational drug injection.