A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Proportion of subjects with dose-limiting toxicity (DLT)
研究概览
简要总结
This is a study to evaluate the safety and tolerability of the study drug HBM1020 which contains two parts. Part 1 will enroll solid tumor participants and Part 2 will enroll renal cell carcinoma (RCC) and colorectal adenocarcinoma (CRC).
详细描述
This is a study to evaluate the safety and tolerability of the study drug HBM1020, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM1020. The study will also look at the anti-tumor activity of HBM1020.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic/unresectable RCC, CRC will receive the MTD and/or RP2D established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.
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
- •Willingness to sign a written informed consent document.
- •Male or female subject aged ≥18 years old at the time of screening.
- •Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
- •Adequate organ and bone marrow function.
排除标准
- •Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb).
- •Any systemic anti-cancer therapy within 4 weeks prior to first dose of investigational medicinal product (IMP), or immunosuppressive medications within 2 weeks before the first dose of investigational medicinal product (IMP).
- •Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
- •With clinically significant congenital or acquired cardiovascular diseases.
- •With severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, autoimmune disease and human immunodeficiency virus.
- •Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
- •Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
- •Previously untreated brain metastases.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
HBM1020
HBM1020 is a recombinant fully human anti-B7H7 monoclonal antibody
干预措施: HBM1020 (Drug)
结局指标
主要结局
Proportion of subjects with dose-limiting toxicity (DLT)
时间窗: From Day 1 until disease progression or Day 21, whichever comes first.
Number of subjects who experience dose-limiting toxicity (DLT) events during 21 days
次要结局
- Objective response rate (ORR)(Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.)
- Duration of response(Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.)
- Time to reach maximum serum concentration (Tmax)(Up to 90 days after end of treatment.)
- Disease control rate(Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.)
- Duration of disease control(Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first)
- Tumor shrinkage (The percentage of patients with tumor shrinkage)(Up to 2 years or until progressive disease, unacceptable toxicity, subject withdraw consent or investigator's decision, whichever occurs first.)
- Adverse events (AEs)(From the date of informed consent until safety follow-up Day 90.)
- Maximum serum concentration (Cmax)(Up to 90 days after end of treatment.)
- Area under the serum concentration versus time curve from time zero to the dosing interval tau (AUC0-tau)(Up to 90 days after end of treatment.)