NCT03272256已完成1 期
A Multi Center, Open-label, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IM156 in Patients With Advanced Solid Tumors and Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability, and to determine the maximum tolerated dose and recommended phase 2 dose of IM156.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 19 years old.
- •Patients histologically or cytologically diagnosed with advanced solid tumor.
- •Patients for whom no standard therapies are available or who have failed in the existing conventional therapies.
- •Patients with a measurable or evaluable lesion by the RECIST v1.1 [for patients with recurrent glioblastoma, the RANO guideline is applied].
- •Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or
- •Patients with the adequate function of bone marrow, kidney and liver as follows.
- •① Absolute Neutrophil Count ≥ 1,500/mm³, Platelet ≥ 100,000/mm³, Hemoglobin ≥ 9.0 g/dL (In case of hemoglobin < 9.0 g/dL, the patient can be enrolled if the value is reversed to ≥ 9.0 g/dL. However, blood transfusion to meet this criterion within 1 week is not allowed.)
- •② Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
- •③ Total bilirubin ≤ 1.5 X UNL, AST, ALT ≤ 3 ×ULN (for patients with liver disease ≤ 5 ×ULN)
- •④ Fasting serum glucose ≤ 160 mg/dL
- •Patients with the life expectancy ≥ 12 weeks.
- •Patients who have agreed to use acceptable methods for contraception during the study treatment period.
- •(e.g.: sterilization of the patient and his/her partner, intrauterine device of the partner, barrier contraception, combination with diaphragm or condom)
- •Patients who have voluntarily signed an informed consent to participate in this clinical study.
排除标准
- •Patients with a history of hypersensitivity to the active ingredient or any component of the investigational product or biguanides.
- •Patients with a current evidence of diabetes mellitus who are currently being treated with another biguanide (e.g., metformin)
- •Patients with a history of serious gastrointestinal bleeding within 6 weeks prior to screening or patients with any disease possibly affecting the absorption of oral agents. (malabsorption syndrome, hemorrhagic gastric ulcer, etc.)
- •At the time of screening,
- •For patients who underwent major surgery, at least 4 weeks have not elapsed after surgery.
- •For patients who underwent radiotherapy, at least 3 weeks have not elapsed from the last treatment day.
- •For patients who underwent chemotherapy, at least 3 weeks have not elapsed from the last treatment day. (6 weeks for nitrosurea compounds).
- •For patients treated with biologic agents including hormone therapy, at least 5 half-lives or 3 weeks, whichever is shorter.
- •Patients who have not been recovered from the toxicities to grade 1 of the therapy received prior to screening.
- •Pregnant women or nursing mothers.
- •Patients who were administered another investigational product within 3 weeks prior to screening.
- •Patients with uncontrolled metastasis to the central nervous system. However, patients with treated and stable brain metastases (stable at least for 30 days on radiology imaging) are allowed to enroll.
- •Patients with suspected serious infectious diseases, intestinal paralysis, bowel obstruction, interstitial pneumonia, or pulmonary fibrosis.
- •Patients with a history of psychiatric disorders likely to threaten the compliance with this protocol.
- •Patients with a history of alcohol or drug abuse within 12 weeks prior to screening.
- •Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C. Patients with no detectable viral load could be enrolled.
- •Patients with severe traumatism.
- •Patients with any clinically significant abnormal intestinal findings that may interfere with the administration, passage, or absorption of the investigational product, which makes the patients unable to orally take the tablet form of drugs.
- •Patients with severe cardiac disorders (e.g. myocardial infarction, congestive heart failure, arrhythmia showing dramatic change in electrocardiogram (ECG), severe or unstable angina, other serious cardiac disorders) or patients with comorbidities of other serious internal disorders (e.g. uncontrolled diabetes mellitus, chronic obstructive pulmonary disorder, renal failure, etc.) on investigator's judgment.
- •Patients who are otherwise considered to be ineligible for this study on investigator's judgment.
研究组 & 干预措施
IM156, Dose escalation
Experimental
干预措施: IM156 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: 4 weeks
Evaluate the safety and tolerability to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
次要结局
- Maximum plasma concentration (Cmax)(4 weeks)
- Time to Cmax (Tmax)(4 weeks)
- Area under the curve (AUC)(4 weeks)
- Plasma half life (T1/2)(4 weeks)
- Volume of distribution (V/F)(4 weeks)
- Plasma Clearance (CL/F)(4 weeks)
- Exploratory Surrogate Biomarker(2 weeks)
- Preliminary tumor response(Every 8 weeks up to end of treatment (EOT))
研究者
研究点 (3)
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