A Phase II Clinical Study to Evaluate the Efficacy and Safety of 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
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recommended Phase II Dose (RP2D)
研究概览
简要总结
This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed 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
- •Voluntarily sign the informed consent and follow the requirements of the protocol;
- •No gender limit;
- •Age ≥18 years old;
- •Expected survival time ≥3 months;
- •Patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
- •Documentation of EGFR sensitive mutations detected from tumor tissue or blood samples;
- •Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 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 blood transfusion is not allowed within 14 days before the screening period and no cell growth factor drugs are allowed;
- •Blood coagulation function: international standardization ratio of 1.5 or less, and the part activated clotting time live enzymes acuities were 1.5 x ULN;
- •Urine 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 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 prior systemic therapy;
- •Previous treatment with EGFR-TKI;
- •Participants who participated in any other clinical trial within 4 weeks before the trial dose;
- •Traditional Chinese medicine (TCM) which had received radiotherapy within 4 weeks before the first use of the study drug and had anti-tumor indications within 2 weeks before the first use of the study drug;
- •Had undergone major surgery within 4 weeks before the first dose;
- •History of severe heart disease or cerebrovascular disease;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Previous history of interstitial lung disease requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
- •Complicated 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;
- •Other malignant tumors within 5 years before the first dose;
- •HIV 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;
- •Severe unhealed wound, ulcer, or fracture within 4 weeks before consent signing;
- •Sign a four weeks before there were clinically significant bleeding or bleeding tendency obviously subjects;
- •Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- •Patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1;
- •A history of severe neurological or psychiatric illness;
- •Pregnant or lactating women;
- •Subjects who were scheduled to receive live vaccine or 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
BL-B01D1+Osimertinib Mesylate Tablets
Participants receive BL-B01D1+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)
BL-B01D1+Osimertinib Mesylate Tablets
Participants receive BL-B01D1+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
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.
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)
- Ctrough(Up to approximately 24 months)
- Cmax(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- ADA (anti-drug antibody)(Up to approximately 24 months)