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Head and Neck Squamous Cell CarcinomaPhase 3NCT07758621

SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC

A Phase 3 study testing SYS6010 and Investigator's Choice of monotherapy in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with 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?
SYS6010 and Investigator's Choice of monotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
No sites listed yet
Study dates
15 Aug 2026to 1 Dec 2028
Phase
Phase 3
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

  • Participantss aged 18-75 years (inclusive);
  • Patients with pathologically confirmed head and neck squamous cell carcinoma (HNSCC);.
  • 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;
  • Participants must have measurable disease according to RECIST (version 1.1);
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Life expectancy of ≥ 3 months;
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  • Adequate major organ function (hematology, renal, liver, and coagulation) as determined by laboratory tests performed within 7 days prior to randomization;
  • 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;
  • Willing to participate in the study, understand the study procedures, and sign a written informed consent form.

Who cannot join

  • Pathologically confirmed patients with adenocarcinoma or sarcomatoid carcinoma etc.;
  • Active central nervous system metastases or leptomeningeal metastasis;
  • History of another malignancy within 3 years prior to randomization
  • Allergy to any component of SYS6010 or to humanized monoclonal antibodies，or to the control drugs (docetaxel, methotrexate, paclitaxel, cetuximab);
  • Prior treatment with TOP1(including ADCs);
  • Prior EGFR mAb therapy within 4 months prior to treatment;
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  • Adverse events from prior antitumor therapy not recovered to Grade ≤ 1 per NCI-CTCAE v6.0；
  • Use of any of the medications or treatments within the specified washout period (prior to randomization )
  • 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;
  • Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; and the investigator assessed that there was no risk of bleeding.
  • 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,
  • 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;
  • Previous permanent discontinuation of EGFR-targeted therapy due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;
  • History of ulcerative colitis or Crohn's disease;
  • Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to randomization;
  • 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;
  • History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;
  • 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.).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

Kunyu Yang contact

About this study

Official title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial Evaluating the Efficacy and Safety of SYS6010 Versus Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is a randomized, controlled, open-label, multicenter phase III clinical trial, which aims to evaluate the efficacy, safety of SYS6010 compared with monotherapy in participants with HNSCC.

Being tested
SYS6010, Investigator's Choice of monotherapy
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.

  • SYS6010Drug

    SYS6010 by intravenous (IV)

  • Investigator's Choice of monotherapyDrug

    Investigator's choice of monotherapy means the therapy chosen by investigators to treat HNSCC including docetaxel (35 mg/m^2 by IV on Day 1、8、15, every 28 days),methotrexate（40 mg/m^2 by IV on Day 1、8、15, every 21 days）, paclitaxel (80 mg/m^2 by IV on Day 1、8、15, every 28 days) or cetuximab（400 mg/m^2 by IV on C1D1, followed by 250 mg/m^2 weekly）.

Study groups in NCT07758621
Study groupRoleWhat they receive
SYS6010ExperimentalSYS6010 monotherapy
Receives: Drug: SYS6010
Investigator's choice of monotherapyActive comparatorInvestigator's choice of one of treatment (docetaxel,methotrexate, paclitaxel or cetuximab)
Receives: Drug: Investigator's Choice of monotherapy

What is being measured

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

  1. Objective Response Rate (ORR) as assessed by IRC per RECIST v.1.1.

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

    Measured: Up to approximately 2 years

  2. Overall Survival

    Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.

    Measured: Up to approximately 2 years

Secondary outcomes (8)

  1. Objective Response Rate (ORR) as assessed by investigators

    Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1

    Measured: Up to approximately 2 years

  2. Duration of Response (DOR)

    DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Disease Control Rate (DCR)

    The percentage of participants who experience a best response of CR, PR or stable disease (SD).

    Measured: Up to approximately 2 years

  4. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.

    Measured: Up to approximately 2 years

  5. Incidence of adverse events assessed by CTCAE v6.0.

    Measured: Up to approximately 2 years

  6. Incidence of Anti-Drug Antibody (ADA)

    Measured: Up to approximately 2 years

  7. Plasma concentrations of toxin-bound antibodies

    Tests are conducted after single and continuous administration of SYS6010.

    Measured: Up to approximately 2 years

  8. Plasma concentrations of total antibodies

    Tests are conducted after single and continuous administration of SYS6010.

    Measured: Up to approximately 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 posted11 Aug 2026
  2. Study start15 Aug 2026 (estimated)
  3. Primary completion15 Sep 2028 (estimated)
  4. Study completion1 Dec 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Eligible Participants in this trial will be randomized in a 1:1 ratio to one of two treatment arms
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07758621
Sponsor's protocol ID
SYS6010-023
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
11 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SYS6010 and Investigator's Choice of monotherapy in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 9 inclusion and 18 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 11 Aug 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) as assessed by IRC per RECIST v.1.1. (time frame: Up to approximately 2 years). 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 NCT07758621.

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 11 Aug 2026.

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