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Can a new drug outperform standard care for head and neck cancer?

NCT ID NCT07758621

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial is testing whether an experimental drug called SYS6010 can better control advanced head and neck cancer compared to standard single-drug treatments. It involves about 340 adults aged 18-75 whose cancer has returned or spread and who have already tried platinum-based chemotherapy and PD-(L)1 inhibitors. Participants will be randomly assigned to receive either SYS6010 or one of several standard chemotherapy or targeted therapy options. The study will measure how well the drug shrinks tumors and whether it helps people live longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYS6010, an experimental drug given by IV, compared with standard single-drug options (docetaxel, methotrexate, paclitaxel, or cetuximab).
What this could lead to
If SYS6010 works, it could offer a new, more effective treatment option for people with advanced head and neck cancer who have run out of standard options.
What could go wrong
This is an early-phase 3 trial, so results are not guaranteed. The drug may not be more effective than existing treatments, and it could have side effects that outweigh benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participantss aged 18-75 years (inclusive); 2. Patients with pathologically confirmed head and neck squamous cell carcinoma (HNSCC);. 3. Participants have failed of platinum-based chemotherapy and PD-(L)1 inhibitors; for participants who received platinum-based chemotherapy and PD-(L)1 inhibitors in the adjuvant/neoadjuvant setting, disease recurrence or progression must have occurred within 6 months after completion of that therapy; radiographically confirmed disease progression during or after the most recent treatment regimen; 4. Participants must have measurable disease according to RECIST (version 1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Life expectancy of ≥ 3 months; 7. Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to randomization; 8. Sexually active fertile participants must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative serum pregnancy test within 7 days prior to randomization; 9. Willing to participate in the study, understand the study procedures, and sign a written informed consent form. Exclusion Criteria: 1. Pathologically confirmed patients with adenocarcinoma or sarcomatoid carcinoma etc.; 2. Active central nervous system metastases or leptomeningeal metastasis; 3. History of another malignancy within 3 years prior to randomization 4. Allergy to any component of SYS6010 or to humanized monoclonal antibodies,or to the control drugs (docetaxel, methotrexate, paclitaxel, cetuximab); 5. Prior treatment with TOP1(including ADCs); 6. Prior EGFR mAb therapy within 4 months prior to treatment; 7. Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v6.0; 8. Use of any of the medications or treatments within the specified washout period (prior to randomization ) 9. History of serious cardiovascular or cerebrovascular conditions within 6 months prior to randomization, including but not limited to: Severe arrhythmias (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, QTcF \> 470 ms) (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate). Myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass surgery. NYHA class II or higher heart failure with LVEF \< 50%.Stroke or other grade ≥ 3 cardiovascular/cerebrovascular events. pulmonary embolism; 10. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding. 11. Patients who have a history of ILD/non-infectious pneumonitis treated with corticosteroids in the past, currently have ILD/non-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD/non-infectious pneumonitis, 12. Severe infection within 4 weeks prior to randomization, such as bacteremia requiring hospitalization, severe pneumonia, or active pulmonary tuberculosis;active systemic infections requiring antibiotics within 2 weeks prior to randomization; 13. Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication; 14. History of ulcerative colitis or Crohn's disease; 15. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization; 16. Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies ≥ 1×10\^4 copies/mL or ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before randomization, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil; 17. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant; 18. Other conditions that the investigator deems unsuitable for participation in this clinical study (such as mental disorders, macular cystoid oedema, severe corneal disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, impaired oxygenation requiring continuous oxygen supplementation, etc.).

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.