OncoMatch/Clinical Trials/NCT07088211
Sacituzumab Tirumotecan and Toripalimab in the First-line Treatment of HNSCC
Is NCT07088211 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07088211 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 CPS ≥ 1 is a required biomarker for enrollment.
Does this trial require TACSTD2?
Yes, TACSTD2 positive expression is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A p16 status required (for oropharyngeal cancer patients) is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify