NCT06672185招募中1 期
A Phase 1 Study of ARC101 in Advanced Solid Tumors
Third Arc Bio23 个研究点 分布在 4 个国家目标入组 70 人开始时间: 2025年2月5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
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 23
- 主要终点
- Frequency and type of dose-limiting toxicities.
研究概览
简要总结
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ARC101 in patients with advanced cancer.
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
- •Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers
- •Measurable or evaluable disease, per RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate organ function
排除标准
- •Active CNS involvement
- •Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
- •Presence of uncontrolled ascites
- •Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels
- •Clinically significant pulmonary compromise
- •Active autoimmune disease within 12 months prior to first dose of study drug.
- •Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
研究组 & 干预措施
Dose Expansion Cohorts
Experimental
ARC101 will be administered at recommended phase 2 dose(s).
干预措施: ARC101 (Drug)
Dose Escalation Cohorts
Experimental
ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
干预措施: ARC101 (Drug)
结局指标
主要结局
Frequency and type of dose-limiting toxicities.
时间窗: Day 1-Day 21 of the first treatment cycle
Occurrence and severity of adverse events, serious adverse events and laboratory values.
时间窗: Day 1 to 100 days after the last dose of study drug.
次要结局
- PK Assessment: Cmax of ARC101(During the intervention/study therapy administration, approximately 1 year on average.)
- PK Assessment: Cmin of ARC101(During the intervention/study therapy administration, approximately 1 year on average.)
- PK Assessment: Tmax of ARC101(During the intervention/study therapy administration, approximately 1 year on average.)
- PK Assessment: AUC of ARC101(During the intervention/study therapy administration, approximately 1 year on average.)
- Overall Response Rate(During the intervention/study therapy administration, approximately 1 year on average.)
- Duration of Response(During the intervention/study therapy administration, approximately 1 year on average.)
- Progression-Free Survival(During the intervention/study therapy administration, approximately 1 year on average.)
- Number of anti-drug antibody (ADA) Positive Participants(During the intervention/study therapy administration, approximately 1 year on average.)
研究者
研究点 (23)
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