A Phase 1 interventional study of MPB-2043 of 0.5 mg/kg and MPB-2043 of 1.0 mg/kg in Head and Neck Squamous Cell Carcinoma and Lymph Node Metastasis, sponsored by MegaPro Biomedical Co. Ltd.. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by MegaPro Biomedical Co. Ltd. · Phase 1, Interventional, and Diagnostic
Among 112 studies in Squamous Cell Carcinoma of Head and Neck with a site in Taiwan — 30 open to participants now, 48 under way, 16 of them phase 3. Squamous Cell Carcinoma of Head and Neck · Taiwan.
Among the 112 studies in Squamous Cell Carcinoma of Head and Neck with a site in Taiwan, this one is the 93rd largest by planned enrollment of the 101 interventional ones, is one of 15 that started in 2024, is one of 24 in phase 1, reaches primary completion later than 7 of the 47 other live ones, and was the 95th registered.
2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
This study's planned enrollment of 24 is below the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →30 of the 112 studies in Squamous Cell Carcinoma of Head and Neck with a site in Taiwan are open now, in 12 countries. Each count lists the studies.
Of the 434 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 310 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →112 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 15 started in 2024.
Median enrollment 205 across the 101 interventional studies, 100 across the 11 observational. Of the 52 that completed or were terminated, 30 (58%) have results posted.
90 of 112 have an industry lead sponsor. The 10 most frequent:
MegaPro Biomedical Co. Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
MegaPro Biomedical Co. Ltd. has 1 study filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
13 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in Taiwan that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT05473156AP Biosciences Inc.A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies | 2026-12 |
| NCT07136545Taipei Veterans General Hospital, TaiwanA Phase I/II Trial of HCB101 in Combination With Pembrolizumab for Patients With Platinum-Refractory, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SirH&N Trial) | 2026-12-31 |
| NCT06727565Gilead SciencesStudy of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 | 2027-03 |
Among the 112 studies in Squamous Cell Carcinoma of Head and Neck with a site in Taiwan, from their registry updates:
This study evaluates the safety and effectiveness of MPB-2043, a superparamagnetic iron oxide (SPIO) contrast agent, for enhancing MRI in detecting metastatic lymph nodes in head and neck cancer. The study compares four doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) and assesses the optimal timing for post-dose imaging using T1/T2/T2*-weighted sequences to improve the accuracy of nodal staging.
The accurate detection of metastatic lymph nodes in subjects with head and neck squamous cell carcinomas is essential for appropriate staging and treatment planning. Traditional imaging techniques often struggle with detecting small nodal metastases due to limitations in resolution and contrast. Superparamagnetic iron oxide (SPIO) particles, such as MPB-2043, have shown promise as MRI contrast agents, particularly in the detection of metastatic lesions in the liver. This study extends the application of SPIO-enhanced MRI to the detection of metastatic cervical lymph nodes.
In this study, T1/T2/T2*-weighted MRI sequences will be used to assess signal intensity (SI) changes in lymph nodes after the administration of MPB-2043. The susceptibility effects of the iron oxide core cause tissue signal loss, which is more pronounced in normal lymph nodes taken up by the reticuloendothelial system, allowing for differentiation from malignant lymph nodes. The study will evaluate the safety and effectiveness of four different doses of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 3 mg/kg) in enhancing the visualization of cervical lymph nodes and will determine the most appropriate timing for post-dose imaging.
The primary objectives include determining the dose that provides optimal contrast enhancement without compromising safety and identifying the time points post-injection that offer the best differentiation between malignant and non-malignant lymph nodes. The results of this pilot feasibility study will inform the development of more extensive clinical trials aimed at improving the diagnostic accuracy of MRI in patients with head and neck squamous cell carcinomas.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
pre- and post-enhanced MRI
Drug: MPB-2043 of 0.5 mg/kg
pre- and post-enhanced MRI
Drug: MPB-2043 of 1.0 mg/kg
pre- and post-enhanced MRI
Drug: MPB-2043 of 2.0 mg/kg
pre- and post-enhanced MRI
Drug: MPB-2043 of 3.0 mg/kg
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Participants will undergo MRI scans without the administration of a contrast agent (unenhanced MRI) and IV-infused MPB-2043 for 1 hour.
Also known as: MPB-2043 enhanced MRI
Sensitivity and Specificity of MPB-2043 Enhanced MRI in Detecting Lymph Node Metastasis
1. Sensitivity is the proportion of true positive lymph nodes (those confirmed as metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change of 20% on T2\*-weighted sequences post-injection is considered indicative of metastasis. 2. Specificity is the proportion of true negative lymph nodes (those confirmed as non-metastatic by pathology) correctly identified by MPB-2043 enhanced MRI. A signal intensity change ≥ 50% on T2\*-weighted sequences post-injection is considered indicative of non-metastasis.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Changes in Signal Intensity of Lymph Nodes in Head and Neck MRI
This outcome measure will assess and compare the changes in signal intensity (SI) in MRI images of lymph nodes in the head and neck region taken before and after the administration of MPB-2043. The SI changes will be evaluated across T1, T2, and T2\*-weighted sequences.
Time frame: From baseline to 10 minutes post-injection, and 24 hours post-injection.
Number and Size of Lymph Nodes Detected in Head and Neck
This outcome measure will record and evaluate the number and size of lymph nodes detected in the head and neck region/level via MRI post-administration of MPB-2043. The effectiveness of MPB-2043 in enhancing lymph node visibility and characterization will be determined by comparing these parameters before and after administration.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Determination of Optimal MPB-2043 Dosage for Lymph Node Imaging in Head and Neck MRI
This outcome measure will determine the most suitable dosage of MPB-2043 (0.5 mg/kg, 1 mg/kg, 2 mg/kg, 3 mg/kg) for optimal MRI contrast enhancement of lymph nodes in the head and neck region. The assessment will be based on post-dose MRI results, specifically evaluating signal intensity changes at 24 hours post-administration.
Time frame: Measured at pre-injection (Baseline) and 24 hours post-injection.
Safety Variables of Adverse Events
• The incidence of all adverse events * Treatment-emergent adverse events (AEs) * Serious AEs * Any AEs leading to withdrawal of study treatment * Any AEs leading to study discontinuation * Any AEs leading to death The data will be categorized and reported based on severity (mild, moderate, severe) and relatedness to the study drug, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From baseline to Day 28 post-MPB-2043 administration.
Safety Variables of Clinical Laboratory Tests
Clinical laboratory and vital sign data will be assessed for safety. This outcome measure evaluates the incidence of abnormal findings in clinical laboratory tests following the administration of MPB-2043. The tests include hematology (e.g., complete blood count), biochemistry (e.g., liver and kidney function tests), coagulation profiles (e.g., PT, INR, aPTT), and urinalysis. Results will be categorized as 'Normal,' 'Abnormal, Not Clinically Significant (NCS),' or 'Abnormal, Clinically Significant (CS).'
Time frame: From baseline to Day 28 post-MPB-2043 administration.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jun 2026, 18 months after the start.
Of 154 industry-sponsored phase 1 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 72. This study's planned 18 months is below that.
Counting every sponsor, half of 267 studies reached it within 49 months; a quarter within 33 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Squamous Cell Carcinoma of Head and Neck →
MegaPro Biomedical Co. Ltd.