jRCT2080225196已完成1 期
A Phase 1, first in human study of DS-1055a in subjects with relapsed or refractory locally advanced or metastatic solid tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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
- 干预模型
- This is a Phase 1, multicenter, open-label, dose escalation, first in human study will evaluate the safety and tolerability of DS-1055a administered by IV infusion as a single agent to subjects with locally advanced or metastatic head and neck cancer, gastric cancer, esophageal cancer, non-small cell lung cancer, or melanoma.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has a histopathologically documented locally advanced or metastatic head and neck, gastric, or esophageal cancer, non-small cell lung cancer, or melanoma. Participants with other types of solid tumors may be eligible following discussion with the Sponsor.
- •Has a relapsed or refractory disease that is not amenable to curative standard therapy.
- •Is 18 years of age or older.
- •Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1, with no deterioration for two weeks.
- •Has a measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Has adequate organ function within 7 days.
- •Is able to provide written informed consent and is willing and able to comply with the protocol.
排除标准
- •Has a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with history of the second malignancy have been disease-free for <3 years.
- •Has a history of (non-infectious) interstitial lung disease (ILD) that required steroids, currently has ILD, or when suspected ILD cannot be ruled out by imaging at screening.
- •Has a history of severe pulmonary compromise or requirement of supplemental oxygen within 6 months before enrollment.
- •Has active hepatitis B or hepatitis C virus infection.
- •Has received prior immunotherapy with a Grade 3 or higher, or any unresolved >=Grade 2 immune-related adverse event.
结局指标
主要结局
safety
To assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose of DS-1055a for further investigation
次要结局
- pharmacokinetics
- incidence of anti-drug antibodies
研究者
研究点 (1)
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