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

NCT07639970 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2026-0308-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer; Head and Neck Cancer (H&N); Pancreatic Cancer; Glioma

Keywords

Urokinase plasminogen activator receptor; Cancer; Radiopharmaceutical

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

Cancers group

EXPERIMENTAL

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

Interventions

[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.

Cancers group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with solid tumors (breast cancer, head and neck cancer, pancreatic cancer, or brain glioma) confirmed by histology or cytology.
• Radiographic evidence of disease progression within 12 months prior to screening (according to RECIST 1.1 criteria).
• At least one measurable target lesion according to RECIST 1.1 criteria.
• Positive uptake in the target lesion on ⁶⁸Ga-HT547 Positron Emission Tomography (PET) scan, with SUV ≥ 4.
• Recovery from toxicities related to prior therapy to ≤ Grade 1 or baseline (except for alopecia, vitiligo, etc.).
• 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.

You may not qualify if:

• 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.
• 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).
• History of other known malignancies within the past 5 years.
• Presence of symptomatic or unstable third-space effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring repeated drainage.
• Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
• Inadequate organ function (meeting any of the following):
• Bone marrow reserve: Neutrophil count \< 1.5 x 10⁹/L, or platelet count \< 100 x 10⁹/L, or hemoglobin \< 90 g/L.
• 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.
• Renal function: Serum creatinine \> 1.5 x ULN and creatinine clearance \< 60 mL/min (calculated by Cockcroft-Gault formula).
• Severe cardiovascular clinical diseases or symptoms that may increase subject safety risk, including:
• Congestive heart failure (New York Heart Association \[NYHA\] class \> II) within the past year.
• Unstable angina within the past year.

Sponsors & Collaborators

• Hua Pang: lead

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Pancreatic Neoplasms; Glioma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Hua Pang, Doctor

CONTACT

+8615923039337; phua1973@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06