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โ† Trials
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SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma

RecruitingPhase 2Ages 18 Years - 75 YearsAllCSPC Megalith Biopharmaceutical Co.,Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18-75 (inclusive) years old, male or females; 2. Participants with histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma who are not suitable for radical surgery or concurrent chemoradiotherapy. 3. 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. 4. 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 (CPSโ‰ฅ1) 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. 5. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria 6. ECOG performance status of 0-1; 7. Life expectancy โ‰ฅ 3 months; 8. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention 9. 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; 10. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form. Exclusion Criteria: 1. 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. 2. 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 โ‰ค10 mg or equivalent doses of other corticosteroids, can participate in the study; 3. 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.; 4. Patients who are known to be allergic to any component of SYS6010, Enlonstobart or Pembrolizumab or to humanized monoclonal antibody products; 5. AEs caused by prior anti-tumor treatment have not recovered to โ‰ค 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; 6. 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; 7. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded: 8. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention 9. Imaging examination suggests tumor invasion of the cervical, thoracic, and abdominal great vessels; 10. 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; 11. 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; 12. Previous interruption of EGFR-targeted therapy for โ‰ฅ1 month or permanent discontinuation due to skin toxicity, or currently have skin diseases requiring oral or intravenous medication; 13. 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. 14. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose; 15. Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies โ‰ฅ 1ร—104 copies/mL or โ‰ฅ 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 thera
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What it tests

  • SYS6010 injection
  • Enlonstobart injection
  • Pembrolizumab injection
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Where

1 site
Shanghai East Hospital Affiliated To Tongji University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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