NCT06927570招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2025年4月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
研究概览
简要总结
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged ≥ 18 years.
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors
- •Standard treatment is invalid, unavailable or intolerable.
- •At least 1 target lesion according to RECIST 1.
- •ECOG PS score: 0-
- •Estimated Life expectancy> 12 weeks.
- •Men or women should be using adequate contraceptive measures throughout the study.
- •Women must have the evidence of non-childbearing potential.
- •Signed and dated Informed Consent Form.
排除标准
- •Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ dysfunction.
- •Evidence of cardiovascular risk.
- •Subjects with severe or poorly controlled diabetes.
- •Subjects with severe or poorly controlled hypertension.
- •Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
- •Subjects with severe arteriovenous thrombotic events within 3 months.
- •Subjects with severe infection within 4 weeks prior to the first dose.
- •Subjects who have received steroid therapy for more than 30 days .
- •Presence of known active infectious diseases.
- •Presence of clinically significant gastrointestinal dysfunction.
- •Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
- •Moderate to severe pulmonary diseases.
- •Prior history of significant neurological or mental disorders.
- •Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- •Hypersensitivity to any ingredient of HS-
- •Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
- •Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ dysfunction.
- •Evidence of cardiovascular risk.
- •Subjects with severe or poorly controlled diabetes.
- •Subjects with severe or poorly controlled hypertension.
- •Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
- •Subjects with severe arteriovenous thrombotic events within 3 months.
- •Subjects with severe infection within 4 weeks prior to the first dose.
- •Subjects who have received steroid therapy for more than 30 days .
- •Presence of known active infectious diseases.
- •Presence of clinically significant gastrointestinal dysfunction.
- •Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
- •Moderate to severe pulmonary diseases.
- •Prior history of significant neurological or mental disorders.
- •Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- •Hypersensitivity to any ingredient of HS-
- •Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
- •Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
研究组 & 干预措施
HS-20122
Experimental
All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage
干预措施: HS-20122 (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
时间窗: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
次要结局
- Incidence of anti-HS-20122 antibody (ADA)(From the date of first dose until 30 days after the final dose.)
- Incidence and severity of adverse events (AEs)(From time of Informed Consent to 28 days post last dose of HS-20122)
- Incidence of dose-limiting toxicities (DLT) as defined in the protocol(From time of first dose of HS-20122 to end of DLT period (approximately 21 days))
- Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)(From the date of first dose until 30 days after the final dose)
- Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)(From the date of first dose until 30 days after the final dose.)
- Area under the curve from time Zero to end of dosing interval (AUC0-t) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)(From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.)
- Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)(From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose)
- Objective response rate (ORR)(up to 24 months)
研究者
研究点 (1)
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