NCT07311603尚未招募1 期
A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2026年1月2日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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 have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.
- •For each tumor type, participants have received prior lines of therapy, where locally available:
- •Non-small cell lung cancer (nonsquamous or squamous)
- •Triple-negative breast cancer
- •Squamous cell carcinoma of head and neck
- •Pancreatic ductal adenocarcinoma
- •Gastric cancer
- •Epithelial ovarian cancer
- •Participants with ECOG Performance Status (ECOG) less than and equal to (<=) 1
- •Participants must have blood, liver, and kidney function within safe levels.
- •Other protocol defined inclusion criteria may apply
排除标准
- •Participant has a history of another 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/hyperplasia, 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 before the date of enrollment). History of hematopoietic allogenic transplantation.
- •Participants with known brain metastases, except those meeting both of the following criteria:
- •All brain metastases 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 more than (>) 1 within 1 week of Cycle1Day
- •Participants with active chronic inflammatory bowel disease and/or bowel obstruction.
- •Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day
- •Other protocol defined exclusion criteria may apply.
研究组 & 干预措施
Part 1: Dose-escalation Cohort
Experimental
干预措施: M7437 (Drug)
Part 2: Dose-Expansion Cohort
Experimental
干预措施: M7437 (Drug)
结局指标
主要结局
Dose-escalation Cohort: Occurences of Dose Limiting Toxicities (DLTs)
时间窗: DLT period is 21 days (cycle 1)
Dose-escalation Cohort: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) and Adverse Event (AEs)
时间窗: Up to end of Part 1 of study (approximately 1 year 8 months)
次要结局
- Dose-escalation Cohort: Plasma Concentration of M7437(Cycle 1 Day 1: Pre-dose, 0.25, 6, 24, 96, 168 and 336 hours post-dose; Cycle 3 Day 1: Pre-dose, 0.25, 6 and 168 hours post-dose; Pre-dose at Day 1 of Cycles 2, 4, 6, 8 until end of treatment (approximately 1 year 8 months) (Each Cycle length=21 days))
- Dose-escalation Cohort: Overall Response (OR) According to Response Evaluation Criteria inSolid Tumor (RECIST) version 1.1 criteria as Assessed by Investigator(From the date of first documented complete response (CR) or partial response (PR), whichever occurs first, until the first documented disease recurrence or progressive disease (PD) (assessed upto [approximately 1 year 8 months]))
- Change From The Baseline Qtc (Δqtc) At Predefined Timepoints Based on Triplicate Electrocardiogram (ECG) Measurements(Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 5, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 3 Day 1 (each cycle is of 21 days))
研究者
研究点 (1)
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