NCT05470933终止1 期
A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors
Suzhou Junjing BioSciences Co., Ltd.1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年8月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Dose limited toxicity (DLT)
研究概览
简要总结
This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort expansion phase).The study includes screening, treatment and follow-up periods.
In phase Ia, accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation.
In phase Ib, specific dose groups will be selected for dose expansion according to PK(Pharmacokinetics) and safety data of different dose groups in dose escalation phase.It is planned that SMC(Safety Monitoring Committee) will select one or more dose groups based on previous data for cohort expansion studies to further determine RP2D, safety tolerability and initial efficacy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with advanced malignant solid tumors clearly diagnosed pathologically and/or cytologically, who have failed to receive standard treatment, or who currently do not/or refuse standard treatment, or who are intolerant to standard treatment;
- •Patient must have at least one measurable lesion as defined per RECIST v1.1;
- •Aged between 18 and 75 (including 18 and 75), male and female patients;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score ≤1;
- •Life expectancy ≥ 3 months;
- •The functions of patients' major organs were basically normal, and the laboratory tests performed within 7 days prior to the first administration of study drugmet the following criteria, Patients must not have required a blood transfusion or growth factor support within 14 days before the examination:
- •Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 × Upper limit of Normal (ULN); Total Bilirubin≤ 1.5×ULN; International Normalized Ratio (INR) ≤1.5; Creatinine ≤ 1.5 × ULN, and Creatinine Clearance Rate (calculated by Cockcroft-Gault formula) ≥ 50 mL/min; Hemoglobin (Hg) ≥ 90g/L; Platelets ≥ 100×10⋀9/L; Absolute Neutrophil Count(ANC) ≥ 1.5×10⋀9/L
- •Fertile women must confirm a negative blood pregnancy test within 7 days prior to the first administration of study drug;All enrolled patients (both male and female) are required to use adequate and effective contraceptive measures throughout the treatment period and within 3 months after the end of treatment;
- •Those who voluntarily participate in the study and sign the written Informed Consent Form upon full informed consent.
排除标准
- •Prior treatment with XPO1 inhibitors;
- •Have a history of allergy to any component or excipient of WJ010175 tablets;
- •Patient with a primary malignancy other than the tumor treated in the study within 5 years prior to the first administration of study drug (exceptions include cured malignancies that did not recur within 3 years prior to enrollment;Basal cell and squamous cell carcinoma completely resected;Complete excision of any type of carcinoma in situ, etc.);
- •Received other anti-tumor therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor therapies (such as anti-tumor traditional Chinese medicine), within 4 weeks or 5 half-life periods (whichever is longer) prior to the first administration of study drug;Or long-term treatment with potent CYP1A2 inhibitors, potent CYP3A4 inducers and potent CYP3A4 inhibition;
- •Thrombosis or embolism occurred within 6 months prior to the first administration of study drug;
- •Received medium or major surgical treatment within 4 weeks prior to the first administration of study drug, other than diagnostic biopsy ;
- •Any of the following conditions within 6 months prior to the first administration of study drug: New York Cardiology Association (NYHA) > Grade II cardiac insufficiency, congestive heart failure, severe/unstable angina pectoris (symptoms of resting angina pectoris), myocardial infarction, arrhythmias requiring treatment, uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy;
- •Adverse events and/or complications caused by previous treatment are not relieved to < Level 2 (per NCI-CTCAE V5.0);Any level of hair loss/pigmentation and long-term toxicity caused by other treatment, other than those that the investigator diagnosiss cannot be recovered and do not affect study administration or compliance and patient safety;
- •Patient with central nervous system metastasis or tumors originating in the central nervous system;,
- •Patient with grade ≥ 2 neuropathy (per NCI-CTCAE V5.0);
- •Severe infections requiring antibiotic treatment within 14 days prior to the first administration of study drug ( > CTCAE Grade 2 ), such as severe pneumonia, bacteremia, infection complications requiring hospitalization;
- •Uncontrolled pericardial effusion, pleural effusion or clinically obvious moderate to severe abdominal effusion during screening is defined as meeting the following criteria: having clinical symptoms and detectable thoracic and abdominal effusion during physical examination;Or in the screening process, the thoracoabdominal effusion needs to be punctured pumping liquid and/or intravenously administered;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Patient has serious psychological or mental abnormalities affecting the compliance of the subjects to participate in the study;
- •With active Hepatitis B, or Hepatitis C, or Human Immunodeficiency Virus positive [HIV (+)] and syphilis antibody (+);Note: Hepatitis B virus surface Antigen (HBsAg) or core antibody (HBcAb) positive should be tested for HBV-DNA, and HBV-DNA should be below the lower limit of the reference range.Patients who are positive for Hepatitis C virus Antibody (HCV Ab) will be tested for HCV RNA and can be enrolled if they are below the upper limit of normal.
- •With Gastrointestinal dysfunction that may affect drug absorption (e.g., intestinal obstruction, inability to swallow tablets, malabsorption syndrome, uncontrollable nausea or vomiting, etc.);
- •Pregnant or lactating women or men who still have reproductive needs;
- •Other conditions that the investigator considers to be ineligible for inclusion, including but not limited to subjects whose body weight is less than ideal and who are expected to be significantly affected by weight change as determined by the investigator.
研究组 & 干预措施
WJ01075 tablets
Experimental
Once a week (QW).
干预措施: WJ01075 (Drug)
结局指标
主要结局
Dose limited toxicity (DLT)
时间窗: 3 years
incidence and severity of Dose limited toxicity(DLT);
Adverse event (AE)
时间窗: 3 years
incidence and severity of adverse event (AE), Abnormal changes in laboratory and other tests of clinical significance;
Maximum tolerated dose (MTD)
时间窗: 2 years
Maximum tolerated dose (MTD)
Recommended phase II dose (RP2D)
时间窗: 2 years
Recommended phase II dose (RP2D)
Serious adverse event (SAE)
时间窗: 3 years
incidence and severity of Serious adverse event (SAE);
次要结局
- Objective response rate(ORR)(2 years)
- Time to response(TTR)(2 years)
- Overall survival (OS)(2 years)
- Fluctuation coefficient (DF)(2 years)
- Clearance rate (CL/F)(2 years)
- Elimination half-life time ( t1/2) and other parameters(2 years)
- Steady state peak concentration(Cssmax)(2 years)
- Duration of response (DOR)(2 years)
- Progression-free survival (PFS)(2 years)
- Maximum plasma concentration (Cmax)(2 years)
- Disease control rate (DCR)(2 years)
- Peak time(Tmax)(2 years)
- Apparent volume of distribution (Vd/F)(2 years)
- Elimination rate constant (λz)(2 years)
- Steady state valley concentration(Cssmin)(2 years)
- Steady state Area under blood concentration - time curve(AUCss)(2 years)
- Area under blood concentration - time curve (AUC)(2 years)
- Steady-state distribution volume(Vss )(2 years)
- Average steady-state plasma concentration(Css-av)(2 years)
- Elimination half-life time ( t1/2)(2 years)
- Accumulation coefficient (AR) and other parameters(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study Explore WJB001 Capsules in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05773820Wigen Biomedicine Technology (Shanghai) Co., Ltd.210
已完成
1 期
A First-in-human Study of HRS2398 Tablets in Subjects With Advanced Malignant TumorsAdvanced Malignant TumorNCT05144061Shanghai Hengrui Pharmaceutical Co., Ltd.28
招募中
1 期
A Clinical Study of TQB2029 for Injection in Subjects With Multiple MyelomaMultiple MyelomaNCT06700395Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.136
已完成
1 期
Safety and Pharmacokinetic Profile of CKD-581Multiple MyelomaLymphomaNCT01580371Chong Kun Dang Pharmaceutical39
招募中
早期 1 期
Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid TumorsNeoplasmsNCT06346041Cancer Institute and Hospital, Chinese Academy of Medical Sciences19