Head and Neck Squamous Cell CarcinomaPhase 2NCT07254585
SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
A Phase 2 study testing SYS6010 injection, Enlonstobart injection and Pembrolizumab injection in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This study is an open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with immunotherapy in the recurrent or metastatic head and neck squamous cell carcinoma. 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 injection, Enlonstobart injection and Pembrolizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 31 Dec 2028
- 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
- Aged 18-75 (inclusive) years old, male or females;
- Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy.
- For SYS6010 combined with Enlonstobart group or SYS6010 combined with Pembrolizumab group : Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.
- For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone systemic antitumor treatment, baseline PD-L1 positivity (CPS≥1) must be confirmed by the 22C3 antibody test,Enrollment can be based on the results of previous 22C3 antibody tests. If previous test results cannot be provided, the test results from the central laboratory shall prevail. for participants who have previously received systemic antitumor treatment, there is no restriction on baseline PD-L1 expression.
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
- ECOG performance status of 0-1;
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- Life expectancy ≥ 3 months;
- Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
- Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.
Who cannot join
- The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or cytologically confirmed combined neuroendocrine carcinoma, mesenchymal tumors or carcinosarcoma.
- Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
- Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
- Patients who are known to be allergic to any component of SYS6010, Enlonstobart or Pembrolizumab or to humanized monoclonal antibody products;
- AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;
- Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have previously received adjuvant/neoadjuvant chemotherapy and experienced disease progression more than 12 months after the end of treatment are allowed to be included;
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- Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded:
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention
- Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels;
- 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, or whose pulmonary function test indicates severe ventilatory dysfunction and/or decreased diffusion capacity;
- Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;
- Previous interruption of EGFR-targeted therapy for ≥1 month or permanent discontinuation due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication;
- Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.
- Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;
- Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies ≥ 1×104 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 the first dose of the study intervention, 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital Affiliated To Tongji University
Shanghai, Shanghai Municipality, 100176
Ye Guo, Ph.D, 13501478472, pattrickguo@gmail.com
About this study
Official title: An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Immunotherapy in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
This study is an open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with immunotherapy in the recurrent or metastatic head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- SYS6010 injection, Enlonstobart injection, Pembrolizumab injection
- 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.
SYS6010 injectionDrug
SYS6010will be administrated on a 14-day cycle
Enlonstobart injectionDrug
Also called Enlonstobart will be administrated on a 14-day cycle
Enlonstobart is a recombinant human anti-PD-1 monoclonal antibody
Pembrolizumab injectionDrug
Also called Pembrolizumab will be administrated on a 42-day cycle
Pembrolizumab is a recombinant human anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 combined with enlonstobart group | Experimental | SYS6010 injection and enlonstobart injection will be administrated on a 14-day cycle Receives: Drug: SYS6010 injection; Drug: Enlonstobart injection |
| Enlonstobart group | Experimental | Enlonstobart injection will be administrated on a 14-day cycle Receives: Drug: Enlonstobart injection |
| SYS6010 combined with pembrolizumab group | Experimental | SYS6010 injection will be administrated on a 14-day cycle and pembrolizumab injection will be administrated on a 42-day cycle Receives: Drug: SYS6010 injection; Drug: Pembrolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR) assessed by investigator
Measured: 1 year
Incidences of Adverse Events and Serious Adverse Events
Measured: 1 year
Secondary outcomes (3)
Progression Free Survival(PFS) and Overall survival(OS)
Measured: 1.5 years
Immunogenicity of SYS6010 and Enlonstobart
Measured: 1 year
The plasma concentration of SYS6010 and Enlonstobart
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start12 Dec 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254585
- Sponsor's protocol ID
- SYS6010-018
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of SYS6010 Combined With Immunotherapy in the Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07254585
- Acronym / sponsor ID
- SYS6010-018
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Nov 2025 (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.
This study is an open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with immunotherapy in the recurrent or metastatic head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYS6010 combined with enlonstobart group | Experimental | Drug: SYS6010 injection, Drug: Enlonstobart injectionSYS6010 injection and enlonstobart injection will be administrated on a 14-day cycle |
| Enlonstobart group | Experimental | Drug: Enlonstobart injectionEnlonstobart injection will be administrated on a 14-day cycle |
| SYS6010 combined with pembrolizumab group | Experimental | Drug: SYS6010 injection, Drug: Pembrolizumab injectionSYS6010 injection will be administrated on a 14-day cycle and pembrolizumab injection will be administrated on a 42-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-75 (inclusive) years old, male or females;
- Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy.
- For SYS6010 combined with Enlonstobart group or SYS6010 combined with Pembrolizumab group : Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy), they are eligible if disease progression occurs at least 6 months after the last administration.
- For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone systemic antitumor treatment, baseline PD-L1 positivity (CPS≥1) must be confirmed by the 22C3 antibody test,Enrollment can be based on the results of previous 22C3 antibody tests. If previous test results cannot be provided, the test results from the central laboratory shall prevail. for participants who have previously received systemic antitumor treatment, there is no restriction on baseline PD-L1 expression.
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
Key exclusion criteria (17 listed)
- The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or cytologically confirmed combined neuroendocrine carcinoma, mesenchymal tumors or carcinosarcoma.
- Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
- Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
- Patients who are known to be allergic to any component of SYS6010, Enlonstobart or Pembrolizumab or to humanized monoclonal antibody products;
- AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia, peripheral neurotoxicity, and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v5.0;
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 |
|---|---|---|
| SYS6010 injectionSYS6010will be administrated on a 14-day cycle | Drug | SYS6010 combined with enlonstobart group, SYS6010 combined with pembrolizumab group |
| Enlonstobart injectionAlso: Enlonstobart will be administrated on a 14-day cycleEnlonstobart is a recombinant human anti-PD-1 monoclonal antibody | Drug | Enlonstobart group, SYS6010 combined with enlonstobart group |
| Pembrolizumab injectionAlso: Pembrolizumab will be administrated on a 42-day cyclePembrolizumab is a recombinant human anti-PD-1 monoclonal antibody | Drug | SYS6010 combined with pembrolizumab group |
Primary outcome
Objective Response Rate(ORR) assessed by investigator
Time frame: 1 year
Incidences of Adverse Events and Serious Adverse Events
Time frame: 1 year
3 secondary outcomes
Progression Free Survival(PFS) and Overall survival(OS)
Time frame: 1.5 years
Immunogenicity of SYS6010 and Enlonstobart
Time frame: 1 year
The plasma concentration of SYS6010 and Enlonstobart
Time frame: 1 year
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 19 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYS6010 injection, Enlonstobart injection and Pembrolizumab injection in people with Head and Neck Squamous Cell Carcinoma, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
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 17 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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) assessed by investigator (time frame: 1 year). 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?
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 Oct 2026.