NCT07530666尚未招募1 期
Phase I/II Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of DS010 in Patients With Cancer Cachexia
Dartsbio Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
研究概览
简要总结
A study to evaluate the safety, tolerability, and preliminary efficacy of DS010 in patients with cancer and cachexia
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
- •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;
排除标准
- •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 ;
研究组 & 干预措施
DS010 expansion 2
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 1
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 2
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 3
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 4
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 5
Experimental
干预措施: DS010 injection (Drug)
DS010 dose level 6
Experimental
干预措施: DS010 injection (Drug)
DS010 expansion 1
Experimental
干预措施: DS010 injection (Drug)
DS010 expansion 3
Experimental
干预措施: DS010 injection (Drug)
DS010 expansion 4
Experimental
干预措施: DS010 injection (Drug)
结局指标
主要结局
Phase 1: Incidence of adverse events as assessed by CTCAE V6.0
时间窗: Up to 20 weeks
Phase 2: Change in body weight from baseline to Week 12
时间窗: Baseline, Week 12
Phase 1: Dose-limiting toxicity (DLT)
时间窗: 21 days after the first dose
次要结局
- Serum concentrations of total GDF-15(Baseline, week 12)
- Changes in lumbar skeletal muscle index (LSMI) measured by CT from baseline(Baseline, week 12)
- Maximum Observed Plasma Concentration (Cmax)(From the first dose to week 12)
- Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb, if applicable)(From the first dose to week 12)
- Functional Assessment of Anorexia/Cachexia Therapy (FAACT) total score and subscale scores from baseline(Baseline, week 12)
- Changes in Patient Global Impression of Severity (PGI-S) from baseline(Baseline, week 12)
- Changes in Patient Global Impression of Change (PGI-C) from baseline(Baseline, week 12)
- Changes in appetite visual analogue scale (VAS) score from baseline(Baseline, week 12)
研究者
研究点 (1)
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