NCT07586124招募中2 期
A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 15
研究概览
简要总结
A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy ≥ 6 months.
- •Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.
- •At least one extracranial measurable lesion per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •No severe cardiac dysfunction.
- •Must provide tumor tissue sample not previously subjected to radiotherapy.
- •Adequate organ function.
- •Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.
排除标准
- •Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid/parathyroid gland, skin, or unknown primary site (squamous cell carcinoma).
- •Head and neck cancer deemed non-resectable by the investigator.
- •Prior treatment with anti-PD-1, anti-PD-L1, MMAE/MMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.
- •Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.
- •Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities/complications. Minor procedures (e.g., vascular access placement, percutaneous/endoscopic head/neck biopsy, tracheostomy tube exchange) are allowed.
- •Grade ≥2 peripheral neuropathy (CTCAE v5.0).
- •Active autoimmune disease requiring systemic treatment within 2 years before first dose.
- •Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.
- •Radiologically detectable central nervous system metastases and/or carcinomatous meningitis.
- •Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.
- •Any severe or uncontrolled systemic disease.
- •Prior or planned allogeneic tissue/solid organ transplantation.
- •Known hypersensitivity to any active ingredient or excipient of the study drugs.
- •Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •Anti-infective therapy within 2 weeks before randomization.
- •Stroke or transient ischemic attack within 6 months before enrollment.
- •Uncontrolled or poorly controlled cardiac disease.
- •Deep or intraluminal bleeding requiring interventional/surgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy.
- •Pulmonary embolism or deep vein thrombosis within 3 months.
- •History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc.
- •Received live vaccine within 30 days before first study dose.
- •History of other primary malignancy.
- •Positive serum pregnancy test or breastfeeding female.
- •Contraindications to study drugs (pucotenlimab and/or becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues.
- •Any condition that the investigator considers unsuitable for participation in the trial.
- •Grade ≥2 hearing impairment per CTCAE v6.0.
研究组 & 干预措施
locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Experimental
干预措施: Becotatug Vedotin for Injection (Drug)
locally advanced resectable HNSCC Becotatug Vedotin +Pucotenlimab
Experimental
干预措施: Pucotenlimab Injection (Drug)
locally advanced resectable HNSCC Placebo +Pucotenlimab
Placebo Comparator
干预措施: Placebo (Drug)
locally advanced resectable HNSCC Placebo +Pucotenlimab
Placebo Comparator
干预措施: Pucotenlimab Injection (Drug)
研究者
研究点 (15)
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