A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete Response Rate(CRR)
研究概览
简要总结
This Phase II study is a clinical trial exploring the efficacy and safety of BL-B01D1 with or without PD-1 monoclonal antibody in patients with high-risk locally advanced nasopharyngeal 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No gender restriction;
- •Age: ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Pathologically confirmed as newly diagnosed nasopharyngeal carcinoma with "non-keratinizing carcinoma (WHO criteria)";
- •Patients with locally regionally advanced nasopharyngeal carcinoma(Stage T4N1M0 or T1-4N2-3M0(AJCC/UICC 9th edition));
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 1 year, or fresh tissue samples;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- •Organ function levels must meet the required criteria;
- •Urine protein ≤1+ or ≤1000 mg/24h;
- •For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment; serum pregnancy test must exclude pregnancy, and patients must be non-lactating; all enrolled trial participants (regardless of male or female) must take adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the completion of treatment.
排除标准
- •Prior receipt of any anti-tumor systemic therapy regimen for nasopharyngeal carcinoma；
- •Use of modern traditional Chinese medicine preparations that have been approved by the NMPA for anti-tumor therapy within 2 weeks prior to the first dose；
- •History of severe cardiac or cerebrovascular disease；
- •Prolonged QTc interval, complete left bundle branch block, second- or third-degree atrioventricular block, or frequent and uncontrolled arrhythmias；
- •Active autoimmune diseases and inflammatory diseases；
- •Diagnosis of active malignancy within 3 years prior to study randomization；
- •Hypertension inadequately controlled by two antihypertensive agents；
- •Trial participants with poorly controlled blood glucose；
- •History of interstitial lung disease/interstitial pneumonia requiring corticosteroid therapy, etc.；
- •Concurrent pulmonary disease resulting in severe impairment of respiratory function；
- •Trial participants with massive serous cavity effusion, or symptomatic serous cavity effusion, or serous cavity effusion that is poorly controlled；
- •Imaging findings indicating tumor invasion or encasement of major blood vessels in the neck, pharynx, or other regions；
- •Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening；
- •Trial participants with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-B01D1；
- •Prior history of organ transplantation or allogeneic hematopoietic stem cell transplantation；
- •Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection；
- •Severe infection occurring within 4 weeks prior to the first use of the investigational drug；
- •History of psychotropic substance abuse that cannot be abstained from, or history of severe neurological or psychiatric disorders；
- •Severe and unhealed wounds, ulcers, or fractures within 4 weeks prior to signing informed consent；
- •Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to the first dose of the investigational drug；
- •Trial participants with inflammatory bowel disease, history of extensive bowel resection, history of immune-mediated enteritis, intestinal obstruction, or chronic diarrhea, etc.；
- •Trial participants who plan to receive or have received live vaccines within 28 days prior to study randomization；
- •Other conditions that, in the investigator's judgment, make the participant unsuitable for participation in this clinical trial due to complications or other reasons.
研究组 & 干预措施
BL-B01D1+PD-1 monoclonal antibody
Participants receive BL-B01D1+PD-1 monoclonal antibody for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-B01D1 (Drug)
BL-B01D1+PD-1 monoclonal antibody
Participants receive BL-B01D1+PD-1 monoclonal antibody for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: PD-1 monoclonal antibody (Drug)
Gemcitabine + Cisplatin
Participants receive Gemcitabine + Cisplatin for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Gemcitabine (Drug)
BL-B01D1
Participants receive BL-B01D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-B01D1 (Drug)
Gemcitabine + Cisplatin
Participants receive Gemcitabine + Cisplatin for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Complete Response Rate(CRR)
时间窗: Up to approximately 24 months
Post-induction therapy complete response rate will be investigated.
次要结局
- Overall Survival (OS)(Up to approximately 24 months)
- Event-free Survival(EFS)(Up to approximately 24 months)
- Distant Metastasis-free Survival(DMFS)(Up to approximately 24 months)
- Locoregional Recurrence-free Survival(LRRFS)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)