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.
Aged 18-75 years, regardless of gender; Histologically or cytologically confirmed newly diagnosed locally advanced, recurrent or metastatic head and neck squamous cell carcinoma (primary tumor sites include oropharynx, oral cavity, hypopharynx, and larynx) that cannot be cured by local treatment. 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); ECOG performance status of 0 or 1; Expected survival period ≥ 12 weeks; At least one measurable lesion according to RECIST 1.1 criteria. Lesions that have received previous radiotherapy can be used as measurable lesions if disease progression occurs; Availability of tumor tissue for PD-L1 detection (paraffin-embedded specimens within 2 years or fresh tumor tissue); PD-L1 CPS ≥ 1 and positive trop2 expression, detected by immunohistochemistry; For oropharyngeal cancer patients, P16 detection status, detected by IHC;
Disease progression occurring within 6 months after systemic treatment for locally advanced head and neck squamous cell carcinoma; A history of primary nasopharyngeal carcinoma; Central nervous system metastasis and/or carcinomatous meningitis; Patients with hearing loss ≥ grade 2 or neuropathy ≥ grade 2 who are currently receiving anti-tumor treatment; Patients who have participated in or are participating in other drug/therapy clinical trials within 4 weeks before the first administration of the study drug; 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; Positive results for HIV antibody or Treponema pallidum antibody tests;
Single group
Sacituzumab Tirumotecan and Toripalimab
DrugThe dosing regimen for the combination of Sacituzumab Tirumotecan and Toripalimab is as follows: the recommended dose of Sacituzumab Tirumotecan is 5mg/kg, administered intravenously every 2 weeks, and Toripalimab is administered intravenously (without prophylactic medication), with a fixed dose of 240mg, and 3mg/kg is used for subjects with baseline body weight\<50kg. Each infusion lasts for 30 minutes (not less than 20 minutes, not more than 60 minutes), administered once every 2 weeks. The subjects will continue to receive combination therapy with Sacituzumab Tirumotecan and Toripalimab until the termination criteria are met.
objective response rate
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Progression Free Survival
PFS was defined as the time from enrollment to the first documented PD per RECIST 1.1, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
overall survival
OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
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