NCT07617727招募中1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 199
- 试验地点
- 6
研究概览
简要总结
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Voluntarily participate and sign the informed consent form.
- •Age ≥ 18 years old, male or female.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or
- •Expected survival ≥ 3 months.
- •Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
- •At least one measurable lesion at baseline according to RECIST 1.1 criteria.
- •Adequate organ function.
- •Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
- •Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
- •Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
- •Adequate washout period of previous therapy before the first dose.
排除标准
- •Complicated with other malignant tumors within 3 years before the first dose.
- •History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
- •Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
- •Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
- •Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
- •Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- •Uncontrolled infection.
- •Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
- •Toxicity of previous anti-tumor treatment has not fully or partially recovered.
- •Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
- •Pregnant and/or lactating women, or planning to become pregnant during the study period.
- •Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
研究组 & 干预措施
Dose escalation cohort 4
Experimental
干预措施: JSKN021 (Drug)
Dose escalation cohort 5
Experimental
干预措施: JSKN021 (Drug)
Dose escalation cohort 2
Experimental
干预措施: JSKN021 (Drug)
Dose escalation cohort 6
Experimental
干预措施: JSKN021 (Drug)
Dose escalation cohort 3
Experimental
干预措施: JSKN021 (Drug)
Dose escalation cohort 1
Experimental
干预措施: JSKN021 (Drug)
Dose optimization cohort 1
Experimental
干预措施: JSKN021 (Drug)
Dose optimization cohort 2
Experimental
干预措施: JSKN021 (Drug)
研究者
研究点 (6)
Loading locations...
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