OncoMatch/Clinical Trials/NCT07088211
Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC
Is NCT07088211 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab Tirumotecan and Toripalimab for recurrent/metastatic head and neck squamous cell carcinoma.
Treatment: Sacituzumab Tirumotecan and Toripalimab — This study is a single center, non controlled, prospective phase II clinical trial to evaluate the efficacy and safety of Sacituzumab Tirumotecan and Toripalimab in the first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients with trop2 and CPS positive. The participants would receive Sacituzumab Tirumotecan and Toripalimab until termination criteria are met.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) CPS ≥ 1 (CPS ≥ 1)
PD-L1 CPS ≥ 1 and positive trop2 expression, detected by immunohistochemistry
Required: TACSTD2 positive expression (positive)
PD-L1 CPS ≥ 1 and positive trop2 expression, detected by immunohistochemistry
Required: CDKN2A p16 status required (for oropharyngeal cancer patients)
For oropharyngeal cancer patients, P16 detection status, detected by IHC
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic treatment for locally advanced head and neck squamous cell carcinoma
Exception: systemic treatment as part of local advanced tumor treatment is allowed, provided that more than 6 months have passed from the end of treatment to the signing of informed consent
No anti-tumor systemic treatment has been received in the recurrent or metastatic stage (systemic treatment as part of local advanced tumor treatment is allowed, provided that more than 6 months have passed from the end of treatment to the signing of informed consent)
Cannot have received: hematopoietic stimulating factors (granulocyte colony-stimulating factor (G-CSF), erythropoietin)
Patients who have received hematopoietic stimulating factors (such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.) within 1 week before the first administration of the study drug
Cannot have received: CYP3A4 inhibitors
Patients who received cytochrome P450 3A4 (CYP3A4) inhibitors within one week before screening
Cannot have received: stem cell transplantation
A history of stem cell transplantation
Cannot have received: organ transplantation
A history of ... organ transplantation
Lab requirements
Blood counts
hemoglobin ≥ 100g/l, white blood cell count ≥ 4.0×10^9/l or neutrophil count ≥ 2.0×10^9/l, platelet count ≥ 100×10^9/l without blood transfusion or colony-stimulating factor support
Kidney function
serum creatinine level < 1.5 times the upper limit of normal or creatinine clearance rate ≥ 60ml/min, blood urea nitrogen ≤ 200mg/l; urinary protein < +; if urinary protein is +, the 24-hour total protein must be < 500mg
Liver function
serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate transaminase (ast) and alanine transaminase (alt) ≤ 1.5 times the upper limit of normal
Cardiac function
no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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