A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A Phase II clinical study to evaluate the efficacy and safety of BL-B01D1 for injection and BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with locally advanced or metastatic non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Sign the informed consent form voluntarily and follow the protocol requirements;
- •Gender is not limited;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with locally advanced or metastatic non-small cell lung cancer confirmed by histopathology and/or cytology;
- •Consent to provide an archived tumor tissue sample or fresh tissue sample from the primary or metastatic site within 6 months for biomarker testing;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •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%;
- •The level of organ function must meet the requirements on the premise that no blood transfusion and no use of any cell growth factor drugs are allowed within 14 days before the screening period;
- •Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- •Urinary protein ≤2+ 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 6 months after the first 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
- •Patients with previous systemic therapy;
- •Cohort_B and Cohort_C were previously treated with EGFR-TKI;
- •Who had participated in any other clinical trial within 4 weeks before the study dose;
- •Received chemotherapy, radiotherapy, biological therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of study drugs;
- •Had undergone major surgery within 4 weeks before the first dose;
- •History of severe heart disease and cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
- •Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- •Severe systemic infection within 4 weeks before screening;
- •Patients at risk for active autoimmune disease or with a history of autoimmune disease;
- •Complicated with other malignant tumors within 5 years before the first dose of medication;
- •Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- •Hypertension poorly controlled by two antihypertensive drugs;
- •Patients with poor glycemic control;
- •Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;
- •Patients with active central nervous system metastases;
- •Imaging examination showed that the tumor had invaded or enveloped the large blood vessels in the abdomen, chest, neck, and pharynx;
- •Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
- •Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- •Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- •Patients with a history of allergy to recombinant humanized antibody or to any of the excipients of BL-B01D1;
- •Had a history of severe neurological or psychiatric disorders;
- •Had a history of autologous or allogeneic stem cell transplantation;
- •Pregnant or lactating women;
- •Subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization;
- •Other conditions for participation in the trial were not considered appropriate by the investigator.
研究组 & 干预措施
Study treatment
Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets in 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)
Study treatment
Participants receive BL-B01D1 and BL-B01D1 in combination with Osimertinib Mesylate Tablets in 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: Osimertinib Mesylate Tablets (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.
Recommended Phase II Dose (RP2D)
时间窗: Up to approximately 24 months
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-B01D1.
次要结局
- Duration of response (DOR)(Up to approximately 24 months)
- Treatment-Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)