NCT07042100招募中1 期
A Phase 1, Multicentre, Open-label, Multiple-dose Study to Determine Safety, Tolerability, and Preliminary Efficacy of SBO-154 in Subjects With Advanced Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 18
- 主要终点
- Incidence of dose-limiting toxicities
研究概览
简要总结
This is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.
详细描述
This study has two parts. In Part 1, the goal to evaluate the safety and tolerability along with the highest dose that can be tolerated, or the dose(s) which can be chosen for further evaluation. In Part 2, the focus is on evaluating the safety of SBO-154 in specific types of advanced cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Willing and able to give written and dated informed consent (or legally acceptable representative/ impartial witness when applicable) and is available for the entire study.
- •Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up.
- •Has locally recurrent or metastatic disease (except sarcomas) which has relapsed or progressed following local standard treatment, or for which no standard treatment is available.
- •Has a life expectancy of ≥3 months.
排除标准
- •Any major surgery, as determined by the Investigator, within 4 weeks of SBO-154 administration.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination.
- •Known or suspected history of significant drug abuse as judged by the Investigator.
- •Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- •Known or suspected history of excessive intake of alcohol in the 12 months prior to study entry.
- •Positive exclusion tests: urine pregnancy tests (if applicable), serology tests positive for HIV, HCV, HBsAg (unless they are considered subjects with resolved Hepatitis B and C infection).
- •History of any relevant allergy/ hypersensitivity including known immediate or delayed hypersensitivity reaction or idiosyncrasy to biological agents or drug chemically related to SBO-154 or its excipients.
- •Received an investigational agent within 30 days or 5 half-lives- whichever is shorter prior to SBO-154 administration.
研究组 & 干预措施
SBO-154
Experimental
干预措施: DL2 (Biological)
SBO-154
Experimental
干预措施: DL3 (Biological)
SBO-154
Experimental
干预措施: Dose level (DL)1 (Biological)
SBO-154
Experimental
干预措施: DL4 (Biological)
SBO-154
Experimental
干预措施: DL5 (Biological)
结局指标
主要结局
Incidence of dose-limiting toxicities
时间窗: Twenty-one days from the initiation of the first dose of SBO-154 (3 weeks)
Applicable to Part 1 only
Incidence of treatment-related serious adverse events
时间窗: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
Incidence of treatment-related adverse events
时间窗: Throughout the study: from the start of study drug to 30 days post the last dose of study drug.
次要结局
- Incidences of neutralizing antibodies(Survival Follow-up: Upto 1 yr)
- To evaluate the overall response rate (i.e., the percentage of participants who achieved a best response of Complete Response (CR) or Partial Response (PR), per RECIST v1.1)(Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.)
- To evaluate the duration of response (i.e., the time from the initial response (CR or PR) to the time of progression of disease (PD) or death, per RECIST v1.1)(Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.)
- To evaluate the disease control rate (i.e., the percentage of participants who achieved a best response of CR, PR, or remained stable disease (SD), per RECIST v1.1)(Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.)
- To evaluate the time to response (i.e., the time from treatment start to the time-point where a best response of CR or PR was achieved, per RECIST v1.1)(Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.)
- To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1)(Time Frame: Assessed every 6 weeks from the date of first study drug administration until the date of first documented disease progression, or death, whatever comes first; assessed for an average of 12 months.)
- Incidences of anti-drug antibodies (ADA)(Survival Follow-up: Upto 1 yr)
- Incidences of titer antibodies(Survival Follow-up: Upto 1 yr)
研究者
研究点 (18)
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