Recurrent or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
SYS6010 combined with enlonstobart group:SYS6010+ enlonstobart by injection
Enlonstobart group:Enlonstobart by injection
Sponsors
Shanghai East Hospital, Tongji University(Shanghai East Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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: 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 (CPS>= 1) must be confirmed by the central laboratory; 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 >= 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
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 = 1 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR) assessed by investigator;Incidences of Adverse Events and Serious Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS) ;Overall survival(OS);Disease Control Rate(DCR);Duration of Response;Pharmacokinetic features of SYS6010 and Enlonstobart;Immunogenicity of SYS6010 and Enlonstobart; | — |
Countries
China
Contacts
Public ContactYe Guo
Shanghai East Hospital
Outcome results
None listed