KCT0006747尚未招募未知
An open-label, dose-escalation, dose-expansion Phase 1 study to evaluate the tolerability, safety, pharmacokinetics/pharmacodynamics, and antitumor effect of ASCA101 in patients with advanced solid tumors
MetaFines0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Patients at the age of =19 years with histopathologically or cytologically confirmed metastatic or unresectable advanced solid tumors which progressed despite standard of care or which did not tolerate standard of care and for which other standard of care is not available.
- •2)Patients whose laboratory test values obtained within 14 days prior to study enrollment satisfy the followings (the patient must not have received G-CSF or blood transfusions within 14 days prior to the laboratory tests):
- •?ANC =1,500/mm³
- •?Platelet count =100,000/mm³
- •?Hemoglobin =9.0 g/dL
- •?Serum creatinine =1.5×ULN
- •?Total bilirubin =1.5×ULN
- •?AST, ALT =3×ULN (=5×ULN for patients with liver metastasis or liver cell carcinoma)
- •?INR and aPTT =1.5×ULN
- •?Urine protein to creatinine ration (UPC) <1.0 (g/g)a
- •a UPC will be performed in patients with one positive (+) protein outcome upon urinalysis.
- •3)At least one evaluable lesion based on the response evaluation criteria in solid tumors (RECIST) version 1.1 as measured by tumor markers or CT/MRI.
- •4)Life expectancy =12 weeks.
- •5)Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •6)Women of childbearing potential must be tested negative for pregnancy (to be performed by serum-hCG or urine-hCG at the discretion of the investigator) at the time of study participation.
- •(All women who had menarche and were not surgically sterile (hysterectomy, bilateral tubal ligation, bilateral ovariectomy, etc.) and were not post-menopausal (no menstruation for =12 months for no particular reasons))
- •7)Patients who agree to use medically acceptable methods of birth control (patient’s or partner’s vasectomy, tubal ligation, intrauterine device, barrier contraception, oral contraceptives, diaphragm or condom use in combination) during treatment with the investigational product (IP) and for 6 months after the end of treatment.
- •8)Patients who voluntarily provided written informed consent to study participation.
排除标准
- •1)History of hypersensitivities to any of the components of the IP or the same class drugs.
- •2)At the time of screening:
- •-<4 weeks from a major surgery, if applicable
- •-<2 weeks from a minor surgery, if applicable
- •-<3 weeks from the last radiotherapy, if applicable
- •-<5 x half-life or <3 weeks, whichever is longer, from chemotherapy or hormone therapy, if applicable (those who were treated with nitrosoureas or mitomycin within 6 weeks prior to screening or targeted biological antibodies within 4 weeks prior to screening are not allowed to participate in the study.)
- •-<4 weeks from anticancer immunotherapy, if applicable
- •3)History of cardiovascular disorders within the past 5 years:
- •-New York heart association (NYHA) class =II (or left ventricle ejection fraction =50%) congestive heart failure (CHF)
- •-Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] >140/90 mmHg)
- •-History of hypertension crisis or hypertensive encephalopathy
- •-Pulmonary hypertension
- •-Myocardial infarction
- •-Significant vascular disease within 6 months prior to IP initiation (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis)
- •-Uncontrolled arrhythmia
- •4)Clinically significant NCI-CTCAE v5.0 Grade =2 toxicities persistent from previous anticancer treatment.
- •5)Severe infection or severe traumatic systemic disorders.
- •6)Symptomatic or uncontrolled metastasis to central nervous system (CNS) (a patient with asymptomatic CNS metastasis may participate in the study if systemic corticosteroids were discontinued =4 weeks prior and the patient is radiologically and neurologically stable for =4 weeks).
- •7)Severe neurological or psychiatric disorders that might have an impact on study results in the opinion of the investigator.
- •8)Pregnant or lactating women or patients planning a pregnancy during the study period.
- •9)Having participated in another clinical trial within 30 days prior to screening.
- •10)History of bleeding or digestive disorders:
- •-Evidence of active bleeding, bleeding diathesis, coagulopathy, or tumor with macrovascular invasion
- •-Clinically significant digestive ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, intra-abdominal abscess, clinical symptoms and signs of GI obstruction, patient requiring parenteral fluids or nutrition, history of digestive disorders such as inflammatory bowel disease
- •-Evidence of abdominal free air unexplained by recent surgery or paracentesis
- •11)Having been treated with biguanides (e.g., metformin) within 2 weeks prior to screening or anticipated to require biguanides during the study period.
- •12)Patient requiring continuous treatment with systemic corticosteroids (the followings will be permitted):
- •-Corticosteroids: use of local corticosteroids such as local intra-articular, intra-nasal, intra-ocular, or inhaled corticosteroids or temporary use of systemic corticosteroids for the treatment and prevention of adverse events (AEs) or allergic reactions to contrast agents will be permitted.
- •13)Patient with HIV and other severe diseases based on which it is difficult to include the patient in the study (medically controlled diseases will be permitted).
- •14)Having ascites and/or pleural fluid drained within 14 days prior to screening.
- •15)Hemoptysis within 14 days prior to screening (=1/2 teaspoonful cherry red blood per episode).
- •16)Core biopsy or any other minor surgical procedure within 14 days pr
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