NCT07166601招募中1 期
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 77
- 试验地点
- 7
- 主要终点
- Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).
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
- •Part 1- M0324 Monotherapy:
- •Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
- •Part 2- M0324 Combination with Pembrolizumab:
- •Participants with certain advanced/metastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.
- •Part 3- M0324 Combination with mFOLFIRINOX:
- •Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted
- •Other protocol defined inclusion criteria could apply
排除标准
- •Has a history of chronic diarrhea greater than or equal to (>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction
- •Participant has a history of malignancy within 3 years before the date of enrollment
- •Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure [New York Heart Association (NYHA) >= II] or a coronary revascularization procedure within 180 days of study entry
- •Life expectancy of less than 3 months
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Part 1: M0324 Monotherapy
Experimental
干预措施: M0324 (Biological)
Part 3: M0324 + mFOLFIRINOX
Experimental
干预措施: M0324 (Biological)
Part 2: M0324 + Pembrolizumab
Experimental
干预措施: M0324 (Biological)
Part 3: M0324 + mFOLFIRINOX
Experimental
干预措施: mFOLFIRINOX (Drug)
Part 2: M0324 + Pembrolizumab
Experimental
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Day 1 up to Day 21
Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Month 40
Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: Day 1 up to Day 35
次要结局
- Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324(From Day 1 up to approximately 40 months)
- Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324(From Day 1 up to approximately 40 months)
- Percent Change from Baseline in Pharmacodynamic Markers(From Day 1 up to approximately 40 months)
- Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months)
- Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator(Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months)
- Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator(Time from first study treatment until progressive disease or death up to approximately 40 months)
- Part 3: Overall Survival (OS)(Time from first study treatment until death, assessed approximately up to 40 months)
- Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324(Up to Month 40)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
1 期
Anti-GD2 ADC M3554 in Advanced Solid TumorsAdvanced Solid TumorNCT06641908EMD Serono Research & Development Institute, Inc.52
已完成
1 期
A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinNCT03900598Janssen Research & Development, LLC226
已完成
1 期
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive MelanomasCutaneous MelanomaUveal MelanomaMucosal MelanomaNCT04551352Hoffmann-La Roche20
终止
1 期
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung CancersLung CancerOvarian CancerNCT06376253Novartis Pharmaceuticals4
招募中
1 期
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid TumorsNon-prostate Extrapulmonary Neuroendocrine CarcinomaCervical Neuroendocrine CarcinomaThymic Neuroendocrine CarcinomaGenitourinary Neuroendocrine CarcinomaUnknown Primary Neuroendocrine CarcinomasMedullary Thyroid CarcinomaMerkel Cell CarcinomaNCT07006727Novartis Pharmaceuticals123