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Head and Neck Squamous Cell CarcinomaPhase 2NCT06509997

A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing MRG003 combined with Dalpicicilip in people with Head and Neck Squamous Cell Carcinoma, run by Lei Liu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
MRG003 combined with Dalpicicilip
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 31 Dec 2027
Phase
Phase 2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old ≤75 years old;
  • Patients with recurrent or metastatic head and neck squamous cell carcinoma (including oral cavity, oropharynx, hypopharynx, larynx, etc.) confirmed by histology or cytology, recurrent patients cannot receive local treatment such as surgery or radiotherapy, and have failed to receive PD-1 (L1) inhibitors and/or platinum drugs in the past, which can be first-line combination regimens or sequential administration. Progression after receiving PD-1 (L1) inhibitors and/or platinum-based drugs;
  • Receive ≤2 lines of treatment;
  • ECOG score 0~1;
  • Lack of CDKN2A function;
  • At least one evaluable lesion according to RECIST (version 1.1) criteria;
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  • Adequate organ function;
  • The expected survival time is greater than 3 months;
  • No serious organic heart disease or arrhythmia;
  • Women of childbearing age (15-49 years) must undergo a pregnancy study within 7 days before starting treatment and the results are negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment;
  • Obtain the "informed consent" voluntarily signed by the patient.

Who cannot join

  • ≥ grade 2 peripheral neuropathy (according to CTCAE 5.0).
  • Surgery or any other form of systemic or local anti-tumor therapy, including maintenance therapy or radiotherapy for head and neck squamous cell carcinoma (including palliative care, except palliative care for non-target lesions), is expected to be required during the study period.
  • Systematic chemotherapy was received within 3 weeks before the first administration of the drug, small molecule targeted therapy was received within 2 weeks before the first administration or 5 half-lives (depending on the time), antitumor biotherapy, macromolecule targeted therapy or immunotherapy was received within 4 weeks before the first administration of the drug. Or major surgery (except minor surgery performed within 2 weeks and complete recovery); Radiotherapy was received within 14 days prior to initial administration of the investigational drug (except for central nervous system radiotherapy, which required a washout period of ≥28 days).
  • Known to have active central nervous system metastasis and/or cancerous meningitis. Patients with treated BMS may participate in the study if their condition is stable and they do not:
  • Progressive or new neurological deficits, seizures, evidence of increased intracranial pressure, vomiting, or headache;
  • MRI shows evidence of enlargement at least 4 weeks before first dosing and at least 14 days before study drug dosing Corticosteroids are required.
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  • Residual toxic effects (except alopecia, fatigue and grade 2 hypothyroidism) caused by previous antitumor therapy (including immunotherapy, targeted therapy, chemotherapy or radiotherapy) or clinically significant laboratory test outliers higher than grade 1 (CTCAE v5.0).
  • Uncontrolled or poorly controlled heart disease, including a history of congestive heart failure (CHF) ≥2 (CTCAE v5.0 or New York Heart Association rating), myocardial infarction, unstable angina, ventricular tachycardia or tip twisting ventricular tachycardia, or arrhythmias requiring treatment within the 6 months prior to admission, For example, men with QTcF > 450 ms and women with QTcF > 470 ms have complete left bundle branch block or third-degree atrioventricular block. QTcF= QT/ (RR^0.33).
  • Pulmonary embolism or deep vein thrombosis (except for catheter-derived thrombosis at infusion port or PICC) occurred within 3 months prior to the first administration of the drug.
  • There is a known prior history of malignancy (except in patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ, or papillary carcinoma of the thyroid who have undergone radical surgery), unless the patient has received potentially curable therapy and has been free of disease recurrence for 5 years since starting treatment. Note: The 5-year recurrence-free time requirement does not apply to head and neck squamous cell carcinoma in patients enrolled in this trial.
  • Any serious or uncontrolled systemic disease, including uncontrolled or poorly controlled hypertension (such as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg), glycosuria (glycated blood red and egg white (HbA1c) >8%), etc.
  • Patients with a history of active bleeding, clotting disorders, or receiving coumarin anticoagulant therapy.
  • Known allergic reactions to any component or excipient of MRG003 (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride and polysorbate 80), or grade ≥3 allergic reactions to other prior anti-EGFR drugs (including investigational drugs) or to other monoclonal antibodies.
  • Known active hepatitis B or C. Active hepatitis B is defined as known HBsAg positive and HBV DNA≥500 IU/mL. Active hepatitis C is defined as a known positive hepatitis C antibody and a known quantitative hepatitis C virus HCV RNA result greater than the lower limit of detection. Other serious liver diseases are present, including chronic autoimmune liver disease, primary biliary cirrhosis or sclerosing cholangitis, alcoholic liver disease, or non-alcoholic steatohepatitis (NASH).
  • Concurrent severe, uncontrolled infection or known human immunodeficiency virus (HIV) (HIV antibody positive) infection, or a diagnosis of acquired immune deficiency syndrome (AIDS); Or uncontrolled autoimmune disease; Have previously received an allogeneic tissue/organ transplant, stem cell or bone marrow transplant, or have previously received a solid organ transplant.
  • Active bacterial, viral, fungal, rickettsial, or parasitic infections requiring systemic anti-infective therapy (unless treatment is obtained and resolves prior to administration of the investigational drug).
  • The live virus vaccine was administered within 30 days prior to the first administration of the investigational drug. Seasonal influenza vaccines or approved COVID-19 vaccines that allow the use of inactivated viruses must be at least one week from the time of first administration.
  • A history of interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, and symptomatic bronchospasm.
  • Immunological based treatment for any reason, including long-term use of a systemic steroid equivalent to >10 mg/ day of prednisone within 7 days before the first administration of the study drug or at any time during study participation. Note: Inhaled or topical steroids or systemic corticosteroids equivalent to ≤10 mg/ day of prednisone are permitted, as are short-term corticosteroids equivalent to >10 mg/ day of prednisone (e.g., prodromal administration before contrast agent administration).
  • Uncontrolled pleural, abdominal, pelvic or pericardial effusions require drainage ≥ once a month.
  • Patients who have tested positive for pregnancy or are breastfeeding. Women and men who do not plan to use adequate contraception during treatment and within 180 days after the last treatment.
  • Any other illness or clinically significant laboratory parameter abnormality, serious medical or psychiatric illness/condition, and substance abuse, including alcohol abuse, that the investigator believes could compromise patient safety, study integrity, affect patient participation in the study or interfere with the purpose of the study and analysis of the results.

About this study

Official title: MRG003 Combined With Dalpicicilip Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma: A Phase II Clinical Trial

A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC). The objective of this study was to evaluate the safety and efficacy of MRG003 combined with the Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant HNSCC.

Read the detailed description

In this study, patients meeting the inclusion criteria were given MRG003 (D1, IVGTT, Q3W) in combination with Darcilil (D1-21, PO, Q4W) after completing the relevant pre-treatment examination until progression or intolerable toxicity occurred. Objective response rate and safety will be the primary outcome measures. Adverse events will also be recorded.

Being tested
MRG003 combined with Dalpicicilip
Keywords
Recurrent/metastatic head and neck squamous cell carcinoma, CDKN2A gene variant, CDK4/6 inhibitor, Antibody-drug conjugate, EGFR inhibitor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRG003 combined with DalpicicilipDrug

    MRG003, intravenous infusion, D1, once every 3 weeks; Dalpicicilip, taking orally, D1-21, once every 4 weeks, maintain use until progression or emergence of intolerable toxicity.

Study groups in NCT06509997
Study groupRoleWhat they receive
MRG003+DalpicicilipExperimentalPatients meeting the inclusion criteria were given MRG003 (D1, IVGTT, Q3W) in combination with Darcilil (D1-21, PO, Q4W) after completing the relevant pre-treatment examination until progression or intolerable toxicity occurred.
Receives: Drug: MRG003 combined with Dalpicicilip

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective response rate

    Measured: approximately 9-10 weeks after start of study treatment

  2. Safety and Tolerability

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: approximately 9-10 weeks after start of study treatment

Secondary outcomes (4)

  1. OS

    overall survival

    Measured: 2 years

  2. PFS

    Progression Free Survival

    Measured: 1-2years

  3. DOR

    Duration of response

    Measured: 1-2years

  4. DCR

    Disease control rates

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A single-arm Phase II clinical trial
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509997
Sponsor's protocol ID
MA-HNC-II-006
Status last verified
Jul 2024
First submitted
10 Jul 2024
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRG003 combined with Dalpicicilip in people with Head and Neck Squamous Cell Carcinoma, run by Lei Liu.

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 11 inclusion and 22 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 19 Jul 2024. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: approximately 9-10 weeks after start of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06509997.

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 19 Jul 2024.

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