This is a single-center, open-label phase 2 study evaluating sacituzumab tirumotecan in combination with an immune checkpoint inhibitor in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma.
Eligible patients will have recurrent or metastatic head and neck squamous cell carcinoma that has progressed after prior standard therapy including an immune checkpoint inhibitor. Sacituzumab tirumotecan, a TROP2-directed antibody-drug conjugate, will be administered by intravenous infusion every 2 weeks in combination with the patient's ongoing immune checkpoint inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of new anticancer therapy, investigator decision, or other protocol-defined discontinuation criteria.
The primary endpoint is objective response rate (ORR), as assessed by the investigator according to RECIST v1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety and tolerability.