A Phase 1 Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered EP102 Monotherapy in Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- To assess the safety and tolerability of EP102 monotherapy
研究概览
简要总结
This the first-in-human (FIH) study for the Investigational Medicinal Product (IMP) EP102, is designed to explore the maximum tolerated dose (MTD), the overall safety profile, its pharmacokinetic (PK) / pharmacodynamic (PD) profile, and an exploratory evaluation of antitumor activity in participants with advanced solid tumors, who have no available standard therapy or who have failed standard therapies.
This study will inform on recommended doses for further studies, e.g. dose optimization studies and / or efficacy and safety studies.
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
- •Participants must have a histological diagnosis of locally advanced or metastatic malignant solid tumors of one of the following cancer types:
- •ovarian cancer
- •cervical cancer
- •endometrial cancer
- •testicular cancer
- •cholangiocarcinoma
- •thyroid cancer
- •parathyroid cancer
- •adrenal cancer
- •pancreatic cancer
- •non-small-cell lung cancer (NSCLC)
- •head-and neck cancer
- •renal cell cancer
- •urethral cancer
- •bladder cancer
- •colorectal cancer
- •gastric cancer
- •esophageal cancer
- •triple-negative breast cancer
- •soft tissue sarcoma
- •Participants must have failed (i.e. progressed on, or been intolerant to standard treatment), or no standard treatment must exist, or they must have refused standard treatment. All participants must have received at least one prior line of systemic therapy.
- •Participants must have at least one measurable lesion per RECIST v1.
- •Participant must have a life expectancy of at least 12 weeks.
排除标准
- •Participants with an active severe infection or unexplained fever > 38.5°C during screening or on the first day of study drug administration are excluded. However, at the Investigator's discretion, participants with tumor-related fever may be enrolled.
- •Participants with known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive in serum), or active hepatitis C virus (HCV) infection (HCV RNA positive in serum).
- •Participants with known dysphagia, short-bowel syndrome, gastroparesis, or any condition that may impair the ingestion or gastrointestinal absorption of orally administered drugs.
- •Pregnant or breastfeeding participants.
- •Participants who have received IMP or devices in other clinical trials within four weeks before the first dose.
- •Participants with prior exposure to selective METTL3 inhibitor therapy.
研究组 & 干预措施
EP102 Dose level 3
干预措施: EP102 (Drug)
EP102 Dose level 4
干预措施: EP102 (Drug)
EP102 Dose level 5
干预措施: EP102 (Drug)
EP102 Dose level 2
干预措施: EP102 (Drug)
EP102 Dose level 1
干预措施: EP102 (Drug)
结局指标
主要结局
To assess the safety and tolerability of EP102 monotherapy
时间窗: Up to 21 Days after first administration
The incidence of adverse drug reactions (ADRs) and serious adverse drug reactions (SARs) during study period
Explore the maximum tolerated dose (MTD) and recommended doses of EP102 monotherapy for subsequent studie
时间窗: Up to 21 Days after first administration
Incidence of Dose Limiting Toxicities (DLT)
次要结局
- To preliminarily evaluate the anti-tumor activity pharmacodynamic (PD) of EP102 monotherapy(Up to 21 days after administration and up until study end)
- To characterize the pharmacokinetic (PK) profile of EP102(Up to 21 Days after first administration)