Breast CancerEarly Phase 1NCT07639970
Evaluation of [⁶⁸Ga/¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid Tumors
A Early Phase 1 study testing [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 in people with Breast Cancer and Head and Neck Cancer (H&N), run by Hua Pang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer (H&N), Pancreatic Cancer
- What is being tested?
- [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- Myocardial infarction within the past year.
- Clinically significant malignant arrhythmia (except for atrial fibrillation, paroxysmal supraventricular tachycardia).
- Presence of clinically significant QTcF prolongation (QTcF > 470 ms, calculated by Fridericia's formula).
- Clinically significant bleeding (e.g., gastrointestinal bleeding, intracranial hemorrhage) within 14 days prior to the first dose.
- Major surgery or significant trauma within 28 days prior to the first dose.
- Any other condition that, in the investigator's judgment, may increase safety risk or interfere with its interpretation.
- Inability of the subject to understand and comply with study instructions and requirements.
- Any other situation deemed inappropriate by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547
- Keywords
- Urokinase plasminogen activator receptor, Cancer, Radiopharmaceutical
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Pancreatic Neoplasms, Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancers group | Experimental | Not described Receives: Drug: [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Pang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Pang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639970
- Sponsor's protocol ID
- 2026-0308-01
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07639970
- Acronym / sponsor ID
- 2026-0308-01
- Conditions
- Breast Cancer, Head and Neck Cancer (H&N), Pancreatic Cancer, Glioma
- Keywords
- Urokinase plasminogen activator receptor, Cancer, Radiopharmaceutical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hua PangUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancers group | Experimental | Drug: [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547All 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. | Drug | Cancers group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [⁶⁸Ga]Ga-HT547 and [¹⁷⁷Lu]Lu-HT547 in people with Breast Cancer and Head and Neck Cancer (H&N), run by Hua Pang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Pang, Doctor (+8615923039337, phua1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: Screening, Day 1 post-⁶⁸Ga-HT547, Day 1, 3, 5, 7 post-¹⁷⁷Lu-HT547). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.