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

June 8, 2026 updated by: Hua Pang

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.
  2. Aged 18 years or older, regardless of gender.
  3. Expected survival of at least 3 months.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  5. Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.
  6. Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria).
  7. At least one measurable target lesion according to RECIST 1.1 criteria.
  8. Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥ 4.
  9. Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.).
  10. For subjects of childbearing potential: Agreement to remain abstinent or use effective contraception (including intrauterine devices, etc.) from signing the ICF until at least 24 weeks after the last dose.

Exclusion Criteria:

  1. Pregnant or breastfeeding women, or women with a positive baseline pregnancy test.
  2. History of severe allergic reaction to any component of the investigational drug injection.
  3. Received blood transfusion within 4 weeks prior to screening to meet the enrollment criteria.
  4. Received immunotherapy, chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
  5. 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).
  6. History of other known malignancies within the past 5 years.
  7. Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
  8. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.

  9. Inadequate organ function (meeting any of the following):

    1. Bone marrow reserve: Neutrophil count < 1.5 x 10⁹/L, or platelet count < 100 x 10⁹/L, or hemoglobin < 90 g/L.
    2. Liver function: AST/ALT > 3 x ULN (> 5 x ULN for subjects with liver metastases), or albumin ≤ 2.8 g/dL, or total bilirubin > 1.5 x ULN.
    3. Renal function: Serum creatinine > 1.5 x ULN and creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula).

  10. Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:

    1. Congestive heart failure (New York Heart Association [NYHA] class > II) within the past year.
    2. Unstable angina within the past year.
    3. Myocardial infarction within the past year.
    4. Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia).
    5. Presence of clinically significant QTcF prolongation (QTcF > 470 ms, calculated by Fridericia's formula).
  11. Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.
  12. Major surgery or significant trauma within 28 days prior to the first dose.
  13. Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.
  14. Inability of the subject to understand and comply with study instructions and requirements.
  15. Any other situation deemed inappropriate by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancers group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy
Time Frame: Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547
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.
Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Pang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0308-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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