A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study is a open, multi-center phase II clinical study to explore the efficacy, safety and pharmacokinetic/pharmacodynamic characteristics of SI-B001+SI-B003 combined with platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Gender is not limited;
- •Age ≥18 years old and ≤75 years old;
- •Expected survival time ≥3 months;
- •Patients with recurrent or metastatic head and neck squamous cell carcinoma;
- •Consent to provide tumor tissue samples or fresh tissue samples archived from the primary or metastatic lesions within 2 years;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •Physical status score: ECOG ≤1;
- •The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- •No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- •No blood transfusion or colony-stimulating factor was allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
- •Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- •Urinary protein ≤1+ or ≤1000mg/24h;
- •Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.
排除标准
- •Squamous cell carcinoma of the nasopharynx, salivary gland, paranasal sinus, skin or of unknown primary site;
- •Patients with any of the following conditions were not eligible for the study: a) suitable and willing for local treatment; b) received systemic therapy, excluding treatment for locally advanced disease as part of multimodal therapy;
- •Patients with active central nervous system metastasis;
- •Who had participated in any other clinical trial within 4 weeks before the study dose;
- •Received radiotherapy within 4 weeks before the first dose of study drug;
- •Use of traditional Chinese medicine with anti-tumor indications within 2 weeks;
- •Had undergone major surgery within 4 weeks before the first dose;
- •Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
- •Pulmonary disease was defined as ≥ grade 3 according to NCI-CTCAE v5.0; Patients with existing or a history of interstitial lung disease (ILD);
- •Have active infection requiring intravenous anti-infective therapy;
- •Had received immunotherapy and had grade ≥3 irAE or grade ≥2 immune-related myocarditis;
- •Received live attenuated vaccine within 4 weeks before the first dose of study drug;
- •Had taken an immunomodulatory drug within 14 days before the first dose of study drug;
- •Patients at risk for active autoimmune disease or with a history of autoimmune disease;
- •Other malignant tumors within 5 years before the first administration;
- •Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- •Poorly controlled hypertension;
- •Patients with poor blood glucose control before the first dose;
- •Had a history of severe cardiovascular and cerebrovascular diseases;
- •Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- •Patients with massive or symptomatic effusions or poorly controlled effusions;
- •Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of SI-B001 or SI-B003;
- •Had severe infusion reactions to antibody therapy in the past;
- •Had autologous or allogeneic stem cell transplantation;
- •Pregnant or lactating women;
- •The investigator did not consider it appropriate to apply other criteria for participation in the trial.
研究组 & 干预措施
Cohort A
Participants will receive treatment during the first cycle. 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: SI-B001 (Drug)
Cohort A
Participants will receive treatment during the first cycle. 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: SI-B003 (Drug)
Cohort B
Participants will receive treatment during the first cycle. 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: SI-B001 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
次要结局
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Duration of response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)