NCT07600749招募中1 期
A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-4884 in Participants With Advanced/Metastatic Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 9
研究概览
简要总结
Researchers are looking for new ways to treat certain types of advanced and/or metastatic solid tumors.
The main goal of this study is to learn about the safety of different doses of MK-4884 and if participants tolerate them.
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
- •Has a histologically or cytologically confirmed diagnosis of 1 of the following unresectable (locally advanced) and/or advanced (metastatic) solid tumors:
- •Colorectal carcinoma (CRC)
- •Renal cell carcinoma (RCC) that contains a clear cell component (with or without sarcomatoid and/or rhabdoid features)
- •Nonsquamous non-small cell lung cancer (NSCLC)
- •Biliary tract cancer (BTC) (intra-or extrahepatic cholangiocarcinoma (CCA)) or gallbladder cancer (GBC)
- •Has measurable disease by Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1)
- •Has adequate organ function
- •Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable antiretroviral therapy (ART) for at least 4 weeks
- •Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Has gastrointestinal malabsorption, a surgical procedure or a condition that could affect the absorption of the study drug
- •Has a history of clinically significant cardiac, cardiovascular and/or cerebrovascular disease
- •Has a serious nonhealing wound, ulcer, or bone fracture
- •Has an active infection(s) requiring systemic therapy
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Known additional malignancy that is progressing or has required active treatment within the past 2 years
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Has a history of stem cell/solid organ transplant
- •Has not adequately recovered from major surgery
研究组 & 干预措施
MK-4884 Dose Escalation Schedule A
Experimental
Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
干预措施: MK-4884 (Drug)
MK-4884 Dose Escalation Schedule B
Experimental
Participants will receive MK-4884 at varying dose levels until any of the criteria for discontinuation of the study intervention are met.
干预措施: MK-4884 (Drug)
研究者
研究点 (9)
Loading locations...
相似试验
尚未招募
1 期
A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid TumorsNCT07566897Philogen S.p.A.96
招募中
2 期
A Phase 2 Study of Tarlatamab in Patients with Small Cell Lung Cancer (SCLC).2024-511837-37-00Amgen Inc.113
尚未招募
1 期
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
招募中
2 期
SKB500 Combinations in Patients With Small Cell Lung CancerSmall Cell Lung CancerNCT07296809Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.80
招募中
3 期
Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)Malignant NeoplasmsNCT07405164Merck Sharp & Dohme LLC450