Becotatug Vedotin Combined With Pucotenlimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma

This is a multicenter, randomized, controlled, Phase II clinical study designed to evaluate the efficacy and safety of neoadjuvant and adjuvant therapy with vebikotamab combined with Pucotenlimab compared to standard treatment in patients with locally recurrent resectable head and neck squamous cell carcinoma (HNSCC). Investigational Arm: The dosing regimen for the investigational arm is as follows: Pucotenlimab: 200 mg per dose, administered intravenously (IV) every 3 weeks (Q3W). No dose adjustments are permitted; however, dosing delays are allowed up to a maximum of 12 weeks from the dat

Trial Details

NCT ID
NCT07632339
Phase
PHASE2
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Becotatug Vedotin combined with Pucotenlimab
  • surgery
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Age between 18 and 75 years, inclusive, regardless of sex; Histologically or cytologically confirmed locally recurrent head and neck squamous cell …
  • Adequate organ function, defined as follows (assessed within 14 days prior to the first dose of the investigational product):
  • Bone Marrow: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹/L, hemoglobin (HB) ≥9 g/dL (no blood transfusions or blood compon…
  • Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of the investigational product; Sexually active m…

For full eligibility, visit ClinicalTrials.gov.

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