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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07254585
What this study is testing
What is SYS6010 injection?
SYS6010 injection is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- For SYS6010 combined with Enlonstobart group: Participants who have not previously received systemic anti-tumor treatment. If participants have...
- For Enlonstobart group: Participants who have not previously received immunotherapy are included. For participants who have not previously undergone...
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
You likely can't join if
- The primary sites include the nasopharynx, salivary glands, sinuses, skin, or squamous cell carcinoma of unknown primary origin; Histologically or...
- Patients with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with...
- Patients with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following...
- Patients who are known to be allergic to any component of SYS6010, Enlonstobart 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...
- Previously received systemic anti-tumor therapy for locally advanced or metastatic non-squamous NSCLC other than EGFR TKI; patients who have...
See the full eligibility criteria
Who can 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: Participants who have not previously received systemic anti-tumor treatment. If participants have received neoadjuvant or adjuvant therapy (or combination targeted therapy)...
- 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...
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
- ECOG performance status of 0-1;
- 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...
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.
What rules you out
- 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...
- 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...
- 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...
- Patients who are known to be allergic to any component of SYS6010, Enlonstobart 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.