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

ConditionsBreast Cancer Head and Neck Cancer (H&N)Pancreatic Cancer Glioma

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-90

SponsorHua Pang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to communicate with the investigator, understand and comply with trial requirements, voluntarily participate in the trial, and provide written informed consent.

Aged 18 years or older, regardless of gender.

Expected survival of at least 3 months.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Disqualifiers

Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.

History of severe allergic reaction to any component of the investigational drug injection.

Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.

Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.

Trial design

Design model

Single group

Treatments tested in this trial

[⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547
Drug
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Cancers groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Diagnostic efficacy

To assess the diagnostic feasibility of uPAR-targeted imaging, including: 1) Tumor uptake intensity (SUVmax, SUVmean) and target-to-background ratios (TBR) on ⁶⁸Ga-HT547 PET/CT; 2) Human radiation dosimetry of ¹⁷⁷Lu-HT547 based on SPECT/CT biodistribution data, estimating organ absorbed doses and effective whole-body dose.

Time frame

Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hua Pang

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Sponsor institution

Source ClinicalTrials.gov

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