NCT06770881尚未招募1 期
Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 430
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Be able to understand informed consent form, voluntarily participate and sign informed consent form.
- •Age ≥18 year (at the time consent is obtained), male or female.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Has a Life expectancy ≥3 months.
- •Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
- •Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
- •Must have adequate organ function prior to the start of JSKN
- •Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.
排除标准
- •Has clinically active brain metastases.
- •Previously received any other investigational drug within 28 days prior to enrollment.
- •Previously received local palliative treatment within 14 days prior to enrollment.
- •Previously received major surgeries within 28 days prior to enrollment.
- •Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
- •Previously received live vaccine within 28 days prior to enrollment.
- •Previously received antibody conjugate drug with topoisomerase I inhibitor.
- •Has a history of other primary malignant tumors within 5 years prior to enrollment.
- •Has uncontrolled comorbidities as specified by the protocol.
- •Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
- •Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
- •Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.
- •Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
- •Has a history of allogeneic bone marrow or organ transplantation.
- •Pregnant or breastfeeding female patients.
- •Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.
研究组 & 干预措施
JSKN033
Experimental
干预措施: JSKN033 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 12 months
Incidence of DLT in the dose escalation period.
Maximum Tolerated Dose (MTD) or recommend Phase II dose (RP2D).
时间窗: Up to 12 months
Based on safety and efficacy data.
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAE) and Treatment Related Adverse Events (TRAE)
时间窗: Throughout the duration of the study, approximately 2 years
TEAE and TRAE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
次要结局
- Anti-drug antibodies (ADA) and neutralizing antibodies(Throughout the duration of the study, about 2 years)
- Objective response rate (ORR)(Throughout the duration of the study, about 2 years)
- Disease control rate (DCR)(Throughout the duration of the study, about 2 years)
- Progression-free survival (PFS)(Throughout the duration of the study, about 2 years)
- Maximum concentration (Cmax)(Throughout the duration of the study, about 2 years)
- Time at which Cmax is reached (Tmax)(Throughout the duration of the study, about 2 years)
- Area under the drug concentration-time curve (AUC) to the last observable concentration (AUClast)(Throughout the duration of the study, about 2 years)
研究者
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