NCT06806046进行中（未招募）1 期
A Phase 1, Open-label Study of Anti-CEACAM5 Antibody-Drug Conjugate Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年12月20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
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and early clinical activity of M9140 in Chinese participants with locally advanced or metastatic colorectal cancer (CRC).
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
- •Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin), an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGF agent. Participants may have received previous treatment with trifluridine/tipiracil and/or regorafenib or fruquintinib, if locally indicated and available. Participants with a known MSI-H status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
- •Participants with adequate hematologic, hepatic and renal function as defined in protocol
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
- •Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
- •Participants with diarrhea (liquid stool) or ileus Grade > 1
- •Cerebrovascular accident/stroke (< 6 months prior to enrollment)
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
M9140
Experimental
干预措施: M9140 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Up to 21 days (Each cycle is of 21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 8 months
次要结局
- Pharmacokinetic (PK) Plasma Concentrations of M9140(Cycle 1 Day 1 (C1D1) - Predose, 6, 24, 168, 336 hr (hour) post dose: predose C2D1; C3D1 - Predose, 6, 24, 336 hr postdose; C4D1 - predose every 2 cycles until treatment discontinuation (20 months). [Each cycle is of 21 days])
- Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators(Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months)
- Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator(Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months)
- Progression-free Survival (PFS) According to RECIST v1.1(Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months)
研究者
研究点 (6)
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