NCT07159126招募中1 期
A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.
详细描述
This is a dose escalation study for participants with advanced or metastatic solid tumors. The primary objective of the study is to determine the Recommended Dose for Expansion (RDE), and to evaluate the safety, tolerability, PK, and preliminary efficacy of DS3610a in solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 and date the main ICF, prior to the start of any trial-specific procedures.
- •Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
- •Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator.
- •Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample.
- •Has measurable disease based on local CT/MRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.
排除标准
- •*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4 weeks Chemotherapy, Ab-based anticancer therapy, immunotherapy: ≤4 weeks Small molecules (eg, tyrosine kinase inhibitors): ≤2 weeks or 5 half-lives, whichever is longer Nitrosoureas: ≤6 weeks
- •Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI/CT of the brain is required for all participants during SCR Period
- •Uncontrolled or clinically significant cardiovascular disease, including the following:
- •Myocardial infarction within 6 months prior to SCR.
- •Uncontrolled angina pectoris within 6 months prior to SCR.
- •New York Heart Association (NYHA) Class III or IV CHF.
- •QTcF interval >470 ms.
- •Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events.
- •Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
研究组 & 干预措施
DS3610a at Escalating Doses
Experimental
Participants will receive DS3610a at escalating doses.
The RDE will be determined using data collected from this arm.
干预措施: DS3610a (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: From first dose, up to approximately 24 months
次要结局
- Area Under the Blood Concentration-time Curve During Dosing Interval(From baseline to postbaseline, up to approximately 36 months)
- Antidrug Antibody Prevalence(From baseline to postbaseline, up to approximately 36 months)
研究者
研究点 (6)
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