NCT07827261尚未招募2 期
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 for injection in combination with glecirasib in the treatment of patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation confirmed by histopathology and/or cytology.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form and comply with protocol requirements;
- •No restriction on gender;
- •Age ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Patients with locally advanced or metastatic non-small cell lung cancer;
- •Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 2 years, or fresh tissue samples;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •ECOG performance status score ≤1;
- •Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
- •Organ function levels must meet the requirements;
- •Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×ULN;
- •Urine protein ≤1+ or <1000 mg/24 h;
- •For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy testing must exclude pregnancy, and the patient must be non-lactating; all enrolled patients (regardless of male or female) should use adequate barrier contraception throughout the entire treatment period and for 7 months after treatment completion.
排除标准
- •Prior treatment with drugs targeting KRAS G12C;
- •Prior use of ADC drugs with small-molecule toxins as topoisomerase I inhibitors;
- •Coexisting other known oncogenic driver gene mutations that can be targeted therapeutically;
- •Prior history of intestinal disease or major gastric surgery;
- •Participation in any other clinical trial within 4 weeks before the first administration of this trial;
- •History of severe heart disease or cerebrovascular disease;
- •Receipt of radical radiotherapy, major surgery, extensive radiotherapy, etc., within 4 weeks before randomization in the study;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
- •History of interstitial lung disease/interstitial pneumonia treated with steroids, etc.;
- •Concurrent pulmonary disease leading to clinically severe impairment of respiratory function;
- •Severe infection occurring within 4 weeks before randomization in the study;
- •Patients at risk of active autoimmune disease, or patients with a history of autoimmune disease;
- •Diagnosis of active malignancy within 5 years before randomization in the study;
- •Positive human immunodeficiency virus antibody, active tuberculosis, active syphilis, active hepatitis B virus infection, or hepatitis C virus infection;
- •Hypertension poorly controlled with two antihypertensive drugs;
- •Patients with poorly controlled blood glucose;
- •Presence of a large amount of serous cavity effusion, or serous cavity effusion with obvious symptoms caused by the serous cavity effusion, etc.;
- •Active central nervous system metastasis;
- •Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, etc.;
- •Severe and unhealed wounds, ulcers, or fractures within 4 weeks before signing informed consent;
- •Trial participants with clinically obvious bleeding or a clear bleeding tendency within 4 weeks before signing informed consent;
- •History of allogeneic stem cell, bone marrow, or organ transplantation;
- •Patients with a history of allergy to recombinant humanized antibodies or allergy to any excipient component of BL-B01D1;
- •History of severe neurological or psychiatric disease;
- •History of autologous or allogeneic stem cell transplantation;
- •Pregnant or breastfeeding women;
- •Trial participants planning to receive vaccination or who received a live vaccine within 28 days before randomization in the study;
- •Other circumstances in which the investigator considers it inappropriate to participate in this clinical trial.
研究组 & 干预措施
BL-B01D1 + Glecirasib
Experimental
Participants receive BL-B01D1 + Glecirasib 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: Glecirasib (Drug)
BL-B01D1 + Glecirasib
Experimental
Participants receive BL-B01D1 + Glecirasib 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)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
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)
研究者
研究点 (1)
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