NCT07072325尚未招募1 期
A Clinical Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Head & Neck Cancers
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Adverse events
研究概览
简要总结
The goal of this prospective, single-center, open-label, dose-escalation study is to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with advanced head and neck cancers who have experienced disease progression (PD) or intolerance to standard systemic therapy (or lack thereof). The main question[s] it aims to answer:
- What is the safety and tolerability profile of CD-001 across escalating doses?
- What is the preliminary efficacy of CD-001 in this patient population?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years , regardless of gender.
- •Patients with advanced head and neck cancer that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
- •ECOG score ≤
- •At least one measurable lesion as defined by RECIST v1.
- •Expected survival ≥ 3 months.
排除标准
- •Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
- •Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
- •Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
- •Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
- •Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
- •At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
- •Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
- •Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.
研究组 & 干预措施
Treatment Cohort
Experimental
CD-001 administered as an intravenous (lV) infusion
干预措施: CD-001 (Drug)
结局指标
主要结局
Adverse events
时间窗: up to 12 months
Adverse events defined as the number of participants with adverse events according
次要结局
- Overall Survival(up to 12 months)
- Objective response rate(up to 12 months)
- Progress-Free Survival(up to 12 months)
研究者
Xingchen Peng
Professor
West China Hospital
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