NL-OMON51516招募中不适用
A Phase 1, Open-Label, Multicenter Study to Assess the Safety and Tolerability of MK-1484 as a Monotherapy and in Combination with Pembrolizumab in Participants with Advanced or Metastatic Solid Tumors - MK1484-001
Merck Sharp & Dohme (MSD)0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •# The participant has provided documented informed consent for this study.
- •# Male or female of at least 18 years at the time of signing the informed
- •consent form.
- •# Histologically- or cytologically-confirmed advanced/metastatic solid tumor by
- •pathology report and received, or intolerant to, all treatment known to confer
- •clinical benefit.
- •# Measurable disease by RECIST 1.1.
- •# Performance status of 0 or 1 on the ECOG Performance Scale (within 7 days
- •before the start of study intervention).
- •# Normal cardiac function based on TTE or MUGA.
- •# Presence of an evaluable archival or newly obtained tumor tissue sample for
- •biomarker analysis.
- •# Adequate organ function (within 7 days before the start of study
- •intervention).
- •# A male participant must agree to use contraception as detailed in the
- •# A female participant is eligible to participate if not pregnant or
- •breastfeeding, agrees to follow the contraceptive guidance as detailed in the
- •protocol, or is not of child-bearing potential.
排除标准
- •# Chemotherapy, definitive radiation or biological cancer therapy within 4
- •weeks (2 weeks for palliative radiation) before the first dose of study
- •intervention.
- •# Not recovered to CTCAE Grade 1 or better from any AEs that were due to cancer
- •therapeutics administered more than 4 weeks earlier.
- •# Currently participating and receiving study intervention in a study of an
- •investigational agent, or participated and received study intervention in a
- •study of an investigational agent, or used an investigational device within 28
- •days of administration of MK-1484.
- •# Received any prior IL-2 based therapy.
- •# Allogeneic tissue/solid organ transplant in the last 5 years or evidence of
- •graft-versus-host disease.
- •# History of a second malignancy, unless potentially curative treatment has
- •been completed with no evidence of malignancy for 2 years.
- •# Clinically active CNS metastases and/or carcinomatous meningitis (exceptions
- •per protocol).
- •# History of severe hypersensitivity reaction to treatment with a monoclonal
- •antibody and/or components of the study intervention(s).
- •# Active infection requiring therapy.
- •# Active autoimmune disease that required systemic treatment in the past 2
- •years (details per protocol).
- •# History of interstitial lung disease, history of (noninfectious) pneumonitis
- •that required steroids, or current pneumonitis.
- •# Known HIV and/or hepatitis B or C infections, or known to be positive for
- •HBsAg/HBV DNA or hepatitis C Antibody or RNA.
- •# History or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the study, interfere with the
- •participant*s participation for the full duration of the study, make
- •administration of the study drugs hazardous, or make it difficult to monitor
- •adverse effects such that it is not in the best interest of the participant to
- •participate, in the opinion of the treating investigator.
研究者
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