NCT07136558尚未招募1 期
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0
研究概览
简要总结
An Open-Label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ICP-B794 in Patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤75 years.
- •Histologically confirmed other locally advanced or metastatic solid tumors.
- •Life expectancy ≥3 months.
- •Adequate organs function within 7 days prior to the first dose of ICP-B794
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1。
- •At least one measurable lesion per RECIST V1.1 criteria.
- •Able to provide archived tumor tissue sample (within 2 years) or fresh tumor tissue sample.
- •Female participants of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening.
- •WOCBP and male participants must agree to use contraceptive method.
- •Female participants must not breastfeed or plan pregnancy during the study and for at least 6 months after the last dose of investigational drug.
- •Participants must be able to communicate effectively with investigators and comply with all study requirements.
- •Participants voluntarily joined the study and signed the informed concent form (ICF).
排除标准
- •Other active primary malignancies within 3 years prior to the first dose of investigational product.
- •Prior or current treatment with the similar drug or related treatment specified in the protocol.
- •Having a past medical history and unhealthy lifestyle history as specified in the protocol, or suffering from diseases as specified in the protocol.
- •Toxicities from prior anti-tumor therapy not recovered to ≤ Grade 1 (per CTCAE V5.0).
- •Major arterial or venous thrombotic events within 3 months prior to first dose.
- •Active bleeding within 2 months prior to screening or history of clinically significant bleeding tendency.
- •Major surgery within 28 days prior to first dose or minor surgery within 2 weeks prior to first dose.
- •Requirement for systemic corticosteroid therapy within 14 days prior to first dose.
- •History of severe hypersensitivity, or known severe hypersensitivity to the active pharmaceutical ingredient, inactive ingredients in the drug product, or antibody-based drugs, or hypersensitivity to recombinant human or murine proteins, or history of severe infusion reaction.
- •Administration of any live vaccine within 4 weeks prior to first dose or history of hypersensitivity reactions of any grade.
- •Female participants who are pregnant, lactating, or planning pregnancy during the study.
- •Any psychiatric or cognitive disorder that may impair understanding or execution of the informed consent document and/or protocol compliance
- •Other conditions determined by the investigator that render patients unsuitable for participation in this study.
研究组 & 干预措施
ICP-B794
Experimental
干预措施: ICP-B794 (Drug)
结局指标
主要结局
Incidence, character, and severity of adverse events (AEs) as judged according to NCI-CTCAE v5.0
时间窗: Up to 2 years
Dose-limiting toxicities (DLT)
时间窗: Up to 2 years
Incidence, character, and severity of dose-limiting toxicities.
The Recommended Dose (RD) of ICP-B794 for expansion and Maximum Tolerated Dose (MTD)
时间窗: Up to 2 years
Objective response rate (ORR)
时间窗: Up to 2 years
次要结局
- Maximum Plasma Concentration (Cmax)(Up to 2 years)
- Time to Maximum Plasma Concentration (Tmax)(Up to 2 years)
- Half-life (T1/2)(Up to 2 years)
- Area under the concentration-time curve from zero time to infinity (AUC0-∞)(Up to 2 years)
- Area under the concentration-time curve from zero time to the last measurable concentration time point t (AUC0-t)(Up to 2 years)
- Apparent Clearance (CL/F)(Up to 2 years)
- Terminal Apparent Volume of Distribution (Vz/F)(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Radiographic progression-free survival (rPFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Number of participants with anti-drug antibodies (ADA) to ICP-B794(Up to 2 years)
研究者
研究点 (1)
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