临床试验/NCT05464030

NCT05464030进行中（未招募）1 期

A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

EMD Serono Research & Development Institute, Inc.66 个研究点分布在 5 个国家目标入组 220 人开始时间: 2022年8月4日最近更新: 2026年7月30日

适应症

干预措施

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: EMD Serono Research & Development Institute, Inc.
入组人数: 220
试验地点: 66
主要终点: Part 2A: Number of Participants with Adverse Events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2)

Study details include:

Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2
M9140 is not available through an expanded access program

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 colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (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
•Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
•Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] >= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms)
•Cerebrovascular accident/stroke (< 6 months prior to enrollment)
•Other protocol defined exclusion criteria could apply

研究组 & 干预措施

Part 2B: M9140

Experimental

干预措施: M9140 (Drug)

Part 1: M9140

Experimental

干预措施: M9140 (Drug)

Part 2A: M9140

Experimental

干预措施: M9140 (Drug)

Part 2C: M9140 + Bevacizumab +/-Capecitabine

Experimental

干预措施: Capecitabine (Drug)

Part 2C: M9140 + Bevacizumab +/-Capecitabine

Experimental

干预措施: M9140 (Drug)

Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab

Experimental

干预措施: Folinic acid (Drug)

Part 2C: M9140 + Bevacizumab +/-Capecitabine

Experimental

干预措施: Bevacizumab (Drug)

Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab

Experimental

干预措施: M9140 (Drug)

Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab

Experimental

干预措施: 5-fluorouracil (5-FU) (Drug)

结局指标

主要结局

Part 2A: Number of Participants with Adverse Events (AEs)

时间窗: up to 8 months

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

时间窗: up to 4 months

Part 1: Recommended Dose Expansion (RDE) of M9140

时间窗: up to 4 months

Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

时间窗: up to 8 months

Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators

时间窗: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months

Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators

时间窗: Time from first study treatment to planned assessment at approximately 8 months

次要结局

Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140(Part 1: Pre-dose up to 4 months; Part 2: Pre-dose up to 8 months)
Parts 1 and 2A: Number of Participants with Clinically Significant Changes from Baseline in Triplicate 12-Lead Electrocardiogram (ECG)(Part 1: up to 4 months; Part 2: up to 8 months)
Parts 1, 2B, 2C and 2D: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator(Time from first study treatment to planned assessment at approximately 4 months and 8 months)
Parts 2A, 2B, 2C and 2D: Time to Response(Time from first study treatment to planned assessment at approximately 8 months)
Parts 1, 2A, 2B, 2C and 2D: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators(Time from first study treatment to planned assessment at approximately 4 months and 8 months)
Parts 2A, 2B, 2C and 2D: Number of Participants with Disease Control(At Week 12)
Parts 1, 2A, 2B, 2C and 2D: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140(Part 1: up to 4 months; Part 2: up to 8 months)
Parts 1, 2A, 2B, 2C and 2D: Levels of Titers of Anti-Drug Antibody (ADA) Against M9140(Part 1: up to 4 months; Part 2: up to 8 months)
Parts 1 and 2A: Change from Baseline in QTc (ΔQTc) Interval(Part 1: baseline, up to 4 months; Part 2: baseline up to 8 months)
Parts 1, 2B, 2C: and 2D: 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 4 months and 8 months)
Part 2A: Overall Survival(Time from first study treatment to planned assessment at approximately 8 months)
Part 2A: Number of Participants with Symptomatic Adverse Events (AEs)(up to 8 months)

研究者

发起方

EMD Serono Research & Development Institute, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (66)

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