Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
A Phase 1/2, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of DS010 as Single Agent in Patients With Advanced Cancer and Cachexia
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Lingyan Chen
- 电话号码：+86 13816915728
- 邮箱：chenlingyan@dartsbio.com
学习地点
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New South Wales
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Concord West、New South Wales、澳大利亚、2138
- 招聘中
- Concord Cancer Centre Medical Oncology Clinical Trials Unit
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接触：
- Tam Bui Kim
- 电话号码：+61 04 5906 4548
- 邮箱：Tam.bui@health.nsw.gov.au
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首席研究员：
- Tam Bui Kim
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Frenchs Forest、New South Wales、澳大利亚、2086
- 招聘中
- Cancer Care Northern Beache
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接触：
- Paul De Souza
- 电话号码：+61 02 8357 5261
- 邮箱：pdesouza@canopycr.com.au
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首席研究员：
- Paul De Souza
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Miranda、New South Wales、澳大利亚、2228
- 招聘中
- Southside Cancer Care Centre
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接触：
- Mahmood Alam
- 电话号码：+61 02 8556 9300
- 邮箱：malam@cancercarefoundation.org.au
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首席研究员：
- Mahmood Alam
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Victoria
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Frankston、Victoria、澳大利亚、3199
- 招聘中
- Peninsula and Southeast Oncology (PASO)
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首席研究员：
- Vinod Ganju
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接触：
- Vinod Ganju
- 电话号码：+61 03 9781 5244
- 邮箱：vg@paso.com.au
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Key Inclusion Criteria:
- Subjects aged ≥ 18 years at screening;
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Able to provide written informed consent;
- ECOG performance status score of 0, 1, or 2;
- Patients with histologically or cytologically confirmed malignant solid tumor;
- Cancer cachexia documented in medical records;
Exclusion Criteria:
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Key Exclusion Criteria:
- History of hypersensitivity or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or molecules composed of monoclonal antibody components;
- Presence of reversible decreased food intake, as determined by the investigator;
- Receiving tube feeding or parenteral nutrition (total or partial parenteral nutrition) at screening;
- Severe gastrointestinal disorders (including esophagitis, gastritis, malabsorption);
- Cachexia caused by other reasons;
- Currently participating in another investigational drug study, or receipt of another investigational product ;
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：DS010 剂量水平 1
|
Once every 3 weeks intravenously injection |
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实验性的：DS010 剂量水平 2
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 剂量水平 3
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 剂量水平 4
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 剂量水平 5
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 剂量水平 6
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 扩展 1
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 扩展 2
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 扩展 3
|
Once every 3 weeks intravenously injection |
|
实验性的：DS010 扩展 4
|
Once every 3 weeks intravenously injection |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
第一阶段：剂量限制性毒性（DLT）
大体时间：首次给药后21天
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首次给药后21天
|
|
第一阶段：根据CTCAE V6.0评估的不良事件发生率
大体时间：最长20周
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最长20周
|
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第2阶段：从基线到第12周的体重变化
大体时间：基线，第12周
|
基线，第12周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
最大观测血浆浓度 (Cmax)
大体时间：从首次给药至第12周
|
从首次给药至第12周
|
|
|
抗药物抗体（ADA）和中和抗体（NAb，如适用）的发生率
大体时间：从首次给药至第12周
|
从首次给药至第12周
|
|
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总GDF-15的血清浓度
大体时间：基线，第12周
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基线，第12周
|
|
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通过CT测量的腰椎骨骼肌指数（LSMI）相对于基线的变化
大体时间：基线，第12周
|
基线，第12周
|
|
|
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline
大体时间：Baseline, week 12
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The total score is derived from the Functional Assessment of Cancer Therapy-General (FACT-G) plus the Anorexia/Cachexia Subscale (ACS). The FAACT total score ranges from 0 to 180, with higher scores indicating better quality of life and less severe anorexia/cachexia symptoms. |
Baseline, week 12
|
|
Changes in Patient Global Impression of Severity (PGI-S) from baseline
大体时间：Baseline, week 12
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The PGI-S is a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater disease severity. |
Baseline, week 12
|
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Changes in Patient Global Impression of Change (PGI-C) from baseline
大体时间：Baseline, week 12
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The PGI-C is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate improvement, and higher scores indicate worsening of condition. |
Baseline, week 12
|
|
Changes in appetite visual analogue scale (VAS) score from baseline
大体时间：Baseline, week 12
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The VAS scale ranges from 0 to 100 mm, where 0 indicates no appetite and 100 indicates the best possible appetite. Higher scores indicate better appetite. |
Baseline, week 12
|
合作者和调查者
调查人员
- 首席研究员：Paul De Souza、Cancer Care Northern Beache
- 首席研究员：Vinod Ganju、Peninsula and Southeast Oncology (PASO)
- 首席研究员：Tam Bui Kim、Concord Cancer Centre Medical Oncology Clinical Trials Unit
- 首席研究员：Mahmood Alam、Southside Cancer Care Centre
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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