jRCT2031250045招募中不适用
A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects with Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 主要终点
- Standard clinical laboratory parameters
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Sign informed consent
- •2.Expected survival > or = 3months
- •Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: Non-Small Cell Lung Cancer, HER2- breast cancer, esophageal cancer, Small Cell Lung Cancer, and Nasopharyngeal Cancer, and HNSCC
- •Agree to provide a tumor sample
- •Has at least one measurable lesion based on RECIST 1.1
- •Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- •Toxicity of previous antitumor therapy has returned to level <=1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase/lipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)
- •Has no serious cardiac dysfunction, left ventricular ejection fraction >=50%.
- •Has adequate organ function before registration
- •Coagulation function: international normalized ratio (INR) <=1.5xULN, and activated partial thromboplastin time (APTT) <=1.5 ULN
- •Urinary protein <=2+ or <=1000mg/24 hours
- •Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months after the last dose of study treatment
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating
排除标准
- •Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration
- •Subjects with history of severe heart disease
- •Active autoimmune diseases and inflammatory diseases
- •Other malignant tumors were diagnosed within 5 years
- •Subjects with poorly controlled hypertension
- •Subjects have Grade 3 lung disease or a history of interstitial lung disease
- •Subjects with stroke (including transient ischemic attack [TIA]), myocardial infarction, or other ischemic event or thromboembolic event (eg, deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months before randomization
- •Symptoms of active central nervous system metastasis
- •Subjects who have a history of allergies to recombinant humanized antibodies or human mouse chimeric antibodies or any of the components of BL-B01D1
- •Subjects have a history of autologous or allogeneic stem cell transplantation
- •Known HIV, active tuberculosis, active Hepatitis B virus infection or active Hepatitis C virus infection
- •Subjects with active infections requiring systemic treatment
- •Participated in another clinical trial within 4 weeks prior to participating in the study
- •Other conditions that the investigator believes that it is not suitable for participating in this clinical trial
- •Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block
- •Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
结局指标
主要结局
Standard clinical laboratory parameters
Standard clinical laboratory parameters measured during the trial
Dose-limiting toxicities (DLTs)
Dose-limiting toxicities observed during the trial
Serious adverse events (SAEs)
Serious adverse events reported during the trial
Treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events observed during the trial
Physical examination findings
Physical examination findings, including ECOG performance status (PS)
Vital sign measurements
Measurements of vital signs during the trial
ECG parameters
ECG parameters measured during the trial
ECHO/MUGA findings
ECHO/MUGA findings observed during the trial
MTD
Maximum tolerated dose
MAD
Maximum administered dose
RDE
Recommended dose for expansion
次要结局
未报告次要终点
研究者
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