A Phase 1 Multi Arm Study Evaluating the Safety, Pharmacology and Preliminary Activity of the Co-Administration of MM-151 With Seribantumab (MM-121), Istiratumab (MM-141), or Trametinib in Biomarker-selected Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
研究概览
简要总结
This is a Phase 1 open-label, dose-escalation trial using "3+3" design, evaluating MM-151 co-administration with MM-121, MM-141, and trametinib at varying dose levels.
详细描述
This is a two-part Phase 1, non-randomized, open-label study of MM-151 plus MM-121, MM-141, or trametinib in patients with advanced, heregulin-positive lung, head and neck, and colorectal cancers. In part 1 of the study, cohorts of 3 or more patients will be treated at escalating doses of MM-151 in combination with MM-121, MM-141, and trametinib until a maximum tolerated combination dose for each combination is identified. In part 2 of the study, patients will be treated with the combination dose identified in part 1 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients must be >18 years of age
- •Patients must be able to provide informed consent
- •Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
- •Patients must be recovered from the effects of any prior surgery, radiotherapy or other antineoplastic therapy, up to CTCAE grade 1
- •Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer.
排除标准
- •Patients who are pregnant or lactating
- •Patients who have an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled.)
- •Patients with untreated (primary) or symptomatic CNS (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
- •Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment.
研究组 & 干预措施
MM-151+MM-121 Dose Escalation
MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
干预措施: MM-151 (Drug)
MM-151+MM-121 Dose Escalation
MM-151 and MM-121 dose escalation in lung, head and neck, and colorectal cancers
干预措施: MM-121 (Drug)
MM-151+ trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
干预措施: MM-151 (Drug)
MM-151+ trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
干预措施: trametinib (Drug)
MM-151+MM-141 Dose Escalation
MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
干预措施: MM-151 (Drug)
MM-151+MM-141 Dose Escalation
MM-151 and MM-141 dose escalation in lung, head and neck, and colorectal cancers
干预措施: MM-141 (Drug)
MM-151+trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
干预措施: MM-151 (Drug)
MM-151+trametinib Dose Escalation
MM-151 and trametinib dose escalation in lung, head and neck, and colorectal cancers.
干预措施: trametinib (Drug)
Colorectal cancer Expansion
Doses established in part 1 of the study
干预措施: MM-151 (Drug)
Colorectal cancer Expansion
Doses established in part 1 of the study
干预措施: MM-121 (Drug)
Colorectal cancer Expansion
Doses established in part 1 of the study
干预措施: MM-141 (Drug)
Colorectal cancer Expansion
Doses established in part 1 of the study
干预措施: trametinib (Drug)
Head and neck Expansion
Doses established in part 1 of the study
干预措施: MM-151 (Drug)
Head and neck Expansion
Doses established in part 1 of the study
干预措施: MM-121 (Drug)
Head and neck Expansion
Doses established in part 1 of the study
干预措施: MM-141 (Drug)
Head and neck Expansion
Doses established in part 1 of the study
干预措施: trametinib (Drug)
结局指标
主要结局
To find a phase II dose of MM-151 in combination with MM-121, MM-141, and trametinib based on maximum tolerated dose (MTD) in patients with lung, head and neck, and colorectal cancers
时间窗: 1.5 years
次要结局
- Number of dose limiting toxicities (DLTs) within a group(1.5 years)
- Adverse event profile of MM-151 in combination with MM-121, MM-141, and trametinib(1.5 years)
- Objective response to MM-151 in combination with MM-121, MM-141, and trametinib based on RECIST(1.5 years)