Pre-surgery sacituzumab govitecan plus tagitanlimab for operable head and neck squamous cell carcinoma

A Single-Arm, Phase II Prospective Study Of Lucanoximab Combined With Tagolimab As Neoadjuvant Therapy For Resectable Head And Neck Squamous Cell Carcinoma

This trial tests whether giving sacituzumab govitecan together with tagitanlimab before surgery helps people with resectable head and neck squamous cell carcinoma have better tumor responses and outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: prednisone, Sacituzumab, Tagitanlimab, immunotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07492914 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label Phase II study enrolling 30 adults with surgically resectable head and neck squamous cell carcinoma at West China Hospital of Sichuan University. Participants receive neoadjuvant sacituzumab govitecan combined with tagitanlimab prior to planned surgery. The trial's main outcomes include major pathological response and safety, with secondary endpoints such as objective response rate, survival measures, quality of life, and exploratory biomarker analyses. No placebo or randomized control arm is used, and participants must have adequate organ function and ECOG 0–2 to enroll.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed resectable head and neck squamous cell carcinoma (excluding nasopharyngeal, salivary gland, and thyroid malignancies), ECOG performance status 0–2, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with unresectable disease, the excluded tumor types (nasopharyngeal, salivary gland, or thyroid cancers), poor organ function, or who cannot undergo surgery are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, the combination could increase pre-surgery tumor shrinkage and potentially improve longer-term disease control and survival for patients with resectable HNSCC.

How similar studies have performed: Combining antibody–drug conjugates like sacituzumab govitecan with immune checkpoint agents has shown early activity in several cancers, but the specific sacituzumab govitecan plus tagitanlimab regimen in resectable HNSCC is a novel application.

Eligibility criteria

Inclusion Criteria:

* Aged 18 years and above, of any gender.
* Histopathologically confirmed resectable head and neck squamous cell carcinoma (HNSCC), excluding nasopharyngeal, salivary gland, and thyroid malignant tumors; surgically assessed as resectable or potentially resectable.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Sufficient organ and bone marrow function, meeting the following: absolute neutrophil count (NEUT) ≥1.5×10⁹/L, platelet count (PLT) ≥80×10⁹/L, hemoglobin ≥8 g/dL; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCR) \>60 mL/min; international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN.
* Voluntarily participate in the study, sign the informed consent form, and be able to comply with scheduled study visits and relevant procedures in the protocol.

Exclusion Criteria:

* A history of other malignant tumors within the past 5 years, except for cured and non-recurrent malignancies (e.g., basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ).
* Active autoimmune disease or relevant medical history (except for type 1 diabetes mellitus under stable insulin therapy), including but not limited to immune neurological diseases, systemic lupus erythematosus, inflammatory bowel disease, autoimmune hepatitis, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
* A history of allergic diseases or severe drug allergy (anaphylaxis requiring hospitalization); known hypersensitivity to anti-PD-L1 antibodies, TROP2 antibody-drug conjugates (ADCs), or excipients of the study drugs.
* Prior anti-tumor treatment involving anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, TROP2 ADCs, or anti-tumor vaccine therapy.
* Receipt of a live infectious vaccine within 4 weeks prior to the first dose or planned vaccination during the study period; major surgery or severe trauma within 4 weeks prior to the first dose.
* Systemic use of corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressants within 14 days prior to the first dose (inhaled or topical steroids and adrenal replacement therapy are permitted).
* Severe medical conditions, including New York Heart Association (NYHA) class II or higher heart failure, ischemic heart disease, clinically significant arrhythmias requiring intervention, left ventricular ejection fraction (LVEF) \<50% on echocardiography, or prolonged QTc interval (males \>450 msec, females \>470 msec).
* A known history of interstitial lung disease or high clinical suspicion of interstitial lung disease; active pulmonary tuberculosis or uncontrolled previous tuberculosis infection.
* Hyperthyroidism or organic thyroid disease (patients with hypothyroidism under stable thyroid hormone replacement therapy are eligible for enrollment).
* Active infection, unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within 1 week prior to signing the informed consent form.
* Active hepatitis B (HBV DNA ≥2000 IU/ml or ≥10⁴ copies/ml), active hepatitis C (positive anti-HCV and HCV RNA above the lower limit of detection), positive HIV antibody, or a history of acquired immunodeficiency syndrome (AIDS).
* A definite history of neurological or psychiatric diseases such as epilepsy or dementia.
* A history of drug or alcohol abuse.
* Pregnant or lactating females; patients (or their partners) planning pregnancy, having unprotected sexual intercourse, or refusing to take effective contraceptive measures during the study and for 3 months after study completion.
* Receipt of other investigational drugs within 4 weeks prior to the first dose, or concurrent participation in other interventional clinical studies (observational or follow-up interventional studies are excluded).
* Other circumstances deemed unsuitable for study participation by the investigator.

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Hong-Shuai Li, Dr

Conditions Resectable Head and Neck Squamous Cell Carcinoma