An Exploratory, Single-arm, Phase II Study of Becotatug Vedotin Combined With a PD-1 Inhibitor in the Treatment of Locally Advanced Recurrent Nasopharyngeal Carcinoma.
This study plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Following treatment, imaging assessment and surgical evaluation will be performed. Subjects deemed operable will undergo endoscopic nasal surgery, after which the MDT (multidisciplinary team) will discuss and determine a maintenance treatment plan. For subjects who are not eligible for surgery, the MDT will decide on either maintenance therapy or a switch to an alternative treatment regimen.
• Written informed consent obtained prior to any trial-related procedures.
• ≥ 18 years of age.
• Histologically or cytologically confirmed recurrent nasopharyngeal carcinoma (locoregional recurrence and/or regional lymph node recurrence), without distant metastases. Including patients with local recurrence at T2 stage and/or retropharyngeal lymph node metastasis adjacent to the internal carotid artery.
• At least one lesion at baseline meeting RECIST 1.1 criteria for target lesions (TL). Tumor assessment must be performed by CT or MRI scan within 28 days before treatment.
• ECOG performance status 0-1.
• Life expectancy ≥ 3 months.
• Adequate organ function for drugs and surgery
• For female patients of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Cycle 1 Day 1) and the result must be negative. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
• If there is a risk of conception, all subjects (male or female) must use contraceptive methods with a failure rate of \< 1% per year during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy, if applicable).