jRCT2041220034招募中不适用
A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and in Combination in Subjects with KRAS G12C Mutant Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 3
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •For all participants:
- •Has measurable disease by RECIST 1.1 criteria
- •Has adequate organ function
- •Male participants must be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic
- •Female participants must not be pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child-bearing potential (WOCBP); is a WOCBP and uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
- •For Arm 1 - Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically OR blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- •Has an untreated metastatic non-small cell lung cancer (NSCLC) with histologically OR blood-based confirmation of KRAS G12C mutation and histologic confirmation of programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) >=1%
- •Has locally advanced unresectable or metastatic solid-tumor malignancy with histologically or blood-based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- •Expansion Group A: 3L/4L metastatic colorectal cancer (mCRC)
- •Has histologically or cytologically confirmed diagnosis of unresectable and metastatic colorectal adenocarcinoma with histological or blood-based confirmation of KRAS G12C mutation
- •Previous treatment failure of 2 or 3 previous lines of systemic therapy
- •Expansion Group B
- •Has locally advanced unresectable or metastatic solid-tumor malignancy, excluding NSCLC or CRC, with histologically or blood- based confirmation of KRAS G12C mutation who has received at least 1 line of therapy for systemic disease
- •Arm 4 only - Has an untreated advanced or metastatic nonsquamous NSCLC with histologically or blood-based confirmation of KRAS G12C mutation
- •Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic colorectal adenocarcinoma and with histologically or blood-based confirmation of KRAS G12C mutation
- •Previous treatment failure of one or 2 previous line(s) of systemic therapy
- •Untreated locally advanced unresectable or metastatic colorectal adenocarcinoma with histologically or blood-based confirmation of KRAS G12C mutation
排除标准
- •Has received chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation)
- •Has a history of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 5 years
- •Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has an active infection requiring systemic therapy
- •Known history of HIV infection or. has a known history of Hepatitis B virus or known active Hepatitis C virus
- •Has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Has a history of interstitial lung disease, noninfectious pneumonitis requiring active steroid therapy, or ongoing pneumonitis
- •Has an active autoimmune disease requiring systemic therapy
- •Has not fully recovered from any effects of major surgical procedure without significant detectable infection
- •Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma; diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and/or a diagnosis of retinal degenerative disease
- •Has received live or live-attenuated vaccine within 4 weeks of study start
- •Is unable to interrupt aspirin or other nonsteroidal anti-inflammatories (NSAIDs), other than an aspirin dose >=1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
- •Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone.
结局指标
主要结局
-
Dose-limiting toxicities (DLTs), Adverse events (AEs), Discontinuation of the study due to an AE
次要结局
未报告次要终点
研究者
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