NCT04122339Unknown1 期
A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Males and/or females over age
- •Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
- •At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
- •Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
- •Life expectancy of at least 3 months.
- •Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.
排除标准
- •Laboratory values not within the Protocol-defined range.
- •Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
- •Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
- •Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
- •Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
- •Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
- •History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
- •Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
研究组 & 干预措施
MAX-10181
Experimental
tablet
干预措施: MAX-10181 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: 8 weeks
Incidence of treatment-related AEs
Maximum tolerated dose (MTD）
时间窗: 4 weeks
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Phase II dose (RP2D)
时间窗: 4 weeks
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
次要结局
- Tmax(Approximately 4 weeks)
- Cmax(Approximately 4 weeks)
- AUC(Approximately 4 weeks)
- t1/2(Approximately 4 weeks)
- Objective response rate (ORR)(12 months (anticipated))
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive MutationLung CancerNCT03420079Ahon Pharmaceutical Co., Ltd.90
已完成
1 期
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)Multiple MyelomaNCT04557150Hoffmann-La Roche225
终止
1 期
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid TumorsSolid TumorsNCT05129280Hoffmann-La Roche23
尚未招募
1 期
IMM40H Phase I Dose Escalation and ExpansionTumorNCT05549557ImmuneOnco Biopharmaceuticals (Shanghai) Inc.16
已完成
1 期
A Phase 1 Study of HS130 in Combination With Viagenpumatucel-L (HS110) in Patients With Solid TumorsAdvanced Solid TumorNCT04116710Heat Biologics15