NCT05388279终止1 期
A Phase I Clinical Study Evaluating the Safety ,Tolerability, Pharmacokinetics of JS012 in Patients With Advanced or Metastatic Solid Tumors
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2022年4月28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
- 3
- 试验地点
- 1
- 主要终点
- Incidence and severity of AE
研究概览
简要总结
The purpose of this phase I clinical study was to evaluate the safety and tolerability of JS012 monotherapy and combination with chemotherapy in patients with Advanced or Metastatic Solid Tumors.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily participated in the study with full informed consent and signed written informed consent form;
- •Aged ≥18 years and ≤70 years when the subject signed the informed consent;
- •Locally advanced unresectable or metastatic malignant solid tumors diagnosed histologically ;
- •Provide past tumor samples or fresh tumor tissue biopsy samples;
- •There should be at least one measurable lesion according to RECIST V1.1 evaluation criteria;
- •The expected survival is ≥3 months;
- •The physical status score is 0 or 1 on the Eastern Oncology Collaboration (ECOG) scale;
- •Good organ function;
- •Any adverse events and/or complications resulting from prior treatment, including surgery or radiation therapy, that have been adequately resolved to level 0 or 1 (according to the NATIONAL Cancer Institute Standard for General Terminology of Adverse Events (NCI-CTCAE 5.0) or to the level specified in the inclusion criteria; Any grade of hair loss/pigmentation and other long-term toxicity caused by treatment, except those that are irreversible and do not affect study dosing/compliance and patient safety at the discretion of the investigator;
- •Within 7 days prior to the first dose, women of reproductive age must be confirmed as having a negative serum pregnancy test and consent to use effective contraception during the duration of study drug use and for 90 days after the last dose. Male patients with a female partner of reproductive age agreed to use effective contraception during the study drug use period and for 90 days after the last dose.
排除标准
- •A history of severe allergic reactions to other monoclonal antibodies or to any component of JS012, or to other drugs or excipients involved in the trial protocol ;
- •Prior treatment with drugs or other therapies targeting CLDN18.2;
- •Malignant tumors other than the target tumor within 5 years before the first dose (except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer, or breast ductal carcinoma in situ);
- •Pregnant or lactation female patients;
- •History of allogeneic organ transplantation or hematopoietic stem cell transplantation;
- •Presence of uncontrolled or symptomatic active central nervous system (CNS) metastases;
- •Poorly controlled pleural effusion, peritoneal effusion or pericardial effusion (thoracoabdominal drainage frequency ≥1 times/month) ;
- •Clinically significant ileus;
- •Poorly controlled tumor-related pain;
- •BMI less than 17.5 at the time of signing the informed consent, or weight loss >10% in the first 2 months (significant pleural effluents should be considered) or other indicators of severe malnutrition;
- •The following within 6 months prior to the first study dose: myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure , hypertensive crisis, or hypertensive encephalopathy; patients with known hypertension, coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be treated with optimal stabilization as determined by the treating physician medical plan;
- •Received a drug or treatment prohibited by the protocol prior to the first dose;
- •Serious infection (CTC AE> grade 2) occurred within 28 days before the first dose, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization, etc.
- •Active infection;
- •History of autoimmune disease;
- •Idiopathic pulmonary fibrosis, drug-induced pneumonia, machine-induced pneumonia (bronchiolitis obliterans), radioactive pneumonia with clinical symptoms or requiring steroid treatment, active pneumonia, or other moderate to severe lung diseases that seriously affect lung function ;
- •Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption;
- •The presence of other serious physical or mental disorders or abnormal laboratory tests, or the presence of alcohol or drug abuse, may increase the risk of study participation, affect treatment compliance, or interfere with study results, as well as other patients deemed unsuitable for study participation by the investigator.
研究组 & 干预措施
JS012
Experimental
干预措施: JS012 (Drug)
JS012 combination with chemotherapy
Experimental
干预措施: JS012 combine with chemotherapy (Combination Product)
结局指标
主要结局
Incidence and severity of AE
时间窗: Up to approximately 41 months from first patient in.
The incidence and severity of adverse events (AE)
Incidence and severity of SAE
时间窗: Up to approximately 41 months from first patient in.
The incidence and severity of serious adverse events (SAE)
MTD
时间窗: Up to approximately 41 months from first patient in.
Determine maximum tolerated dose (MTD, if possible)
RP2D
时间窗: Up to approximately 41 months from first patient in.
Recommended phase II dose (RP2D) for JS012 monotherapy and combination therapy
Incidence of DLT
时间窗: Up to approximately 41 months from first patient in.
The Incidence of dose-limiting toxicity（DLT）
次要结局
- Drug concentrations(Up to approximately 41 months from first patient in.)
- Cmax(Up to approximately 41 months from first patient in.)
- Tmax(Up to approximately 41 months from first patient in.)
- Ctrough(Up to approximately 41 months from first patient in.)
- AUC0-T(Up to approximately 41 months from first patient in.)
- AUC0-INF(Up to approximately 41 months from first patient in.)
- t1/2(Up to approximately 41 months from first patient in.)
- CL(Up to approximately 41 months from first patient in.)
- MRT(Up to approximately 41 months from first patient in.)
- Vss(Up to approximately 41 months from first patient in.)
- Css, Max(Up to approximately 41 months from first patient in.)
- Css, min(Up to approximately 41 months from first patient in.)
- AUCss(Up to approximately 41 months from first patient in.)
- Rac(Up to approximately 41 months from first patient in.)
- Immunogenicity(Up to approximately 41 months from first patient in.)
- ADCC(Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases)
- CDC(Up to 21 days from pre-dose of JS012 administration in cycle 1 for each subject in the dose escalation and dose expansion phases)
- ORR(Up to approximately 41 months from first patient in.)
- DOR(Up to approximately 41 months from first patient in.)
- DCR(Up to approximately 41 months from first patient in.)
- TTR(Up to approximately 41 months from first patient in.)
- PFS(Up to approximately 41 months from first patient in.)
- OS(Up to approximately 41 months from first patient in.)
研究者
研究点 (1)
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