jRCT2031230234招募中不适用
FIRST-IN-HUMAN STUDY OF DS-1471A IN SUBJECTS WITH ADVANCED SOLID TUMORS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 主要终点
- Safety
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
- Single Arm Study
- 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
- •The clinical sites will screen for the full inclusion criteria per protocol.
- •Sign and date the informed consent form (ICF)
- •Adults >=18 years at the time the ICF is signed
- •Has a histologically or cytologically documented, locally advanced, metastatic, or unresectable solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- •Has at least 1 measurable lesion according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI)
- •Is willing and able to provide tumor tissue (newly obtained or archival)
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Life expectancy >=3 months
- •Has a left ventricular ejection fraction (LVEF) >=50% within 28 days prior to Cycle 1 Day 1
- •Required baseline local laboratory data (within 7 days prior to Cycle 1 Day 1) as prespecified in the protocol
- •If the participant is a female of childbearing potential, she must have a negative highly sensitive pregnancy test within 7 days prior to study drug administration (Cycle 1 Day 1) and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug
- •If male, the participant must avoid donating sperm and willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 4 months following the last dose of study drug
- •Is willing and able to comply with scheduled visits, study drug administration plan, laboratory tests, other study procedures, and study restrictions
- •Patients with liver cirrhosis and/or hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria.
排除标准
- •Has an inadequate treatment washout period prior to start of study treatment (Cycle 1 Day1) as prespecified in the protocol
- •Has history of or current presence of untreated central nervous system (CNS) metastases
- •Has a history of leptomeningeal carcinomatosis
- •Has a history of (non-infectious) interstitial lung disease (ILD) other than radiation pneumonitis, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- •Has any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, arterial thromboembolic event, or pulmonary embolism
- •Has uncontrolled or clinically significant cardiovascular disease
- •Is requiring chronic steroid treatment (>10 mg daily prednisone equivalents)
- •Has multiple primary malignancies, except adequately resected nonmelanoma skin cancer, curatively treated in situ disease, superficial cancer in the gastrointestinal tract curatively resected by endoscopic surgery, or any other solid tumors curatively treated with no evidence of recurrent disease for >=3 years
- •Has unresolved toxicities from previous anticancer treatment, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCICTCAE) Version (v)5.0, Grade <=1 or baseline
- •Exposure to another investigational medical product within 4 weeks prior to Cycle 1 Day 1 or current participation in other therapeutic investigational procedures
- •Has any known contraindication to treatment with, including hypersensitivity to the study drug substances or inactive ingredients in the study drug product
- •Has an active, known, or suspected autoimmune disease
- •Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
- •Has an active hepatitis or uncontrolled hepatitis B or C infection, except for participants with hepatitis B infection that is controlled by antiviral therapy
- •Has human immunodeficiency virus (HIV) infection with exceptions per protocol for participants in Dose Expansion
- •Has received a live, attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug (Cycle 1 Day 1)
- •Female who is pregnant or breastfeeding
- •Has psychological, social, familial, or geographical factors that would prevent regular follow-up
- •Has prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results
- •Patients with hepatocellular carcinoma (HCC) may be eligible to participate if they meet additional protocol specified criteria.
结局指标
主要结局
Safety
Dose Expansion Phase: To evaluate the overall safety of DS-1471a at the RDE(s)
次要结局
未报告次要终点
研究者
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