CTRI/2025/09/095114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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 3
- 主要终点
- 1. Incidence of dose-limiting toxicities (Applicable to Part 1 only)
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 responded to previous treatment with standard therapy available in the country. The study involves multiple doses and takes place at several centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 and be accessible for followup.
- •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 or more.
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.
- •Known or suspected history of significant drug abuse as judged by the Investigator examination.
- •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.
结局指标
主要结局
1. Incidence of dose-limiting toxicities (Applicable to Part 1 only)
时间窗: From baseline until 30 days after last dose of SBO-154 or longer if required
2. Incidence of treatment-related serious adverse events
时间窗: From baseline until 30 days after last dose of SBO-154 or longer if required
3. Incidence of treatment-related adverse events
时间窗: From baseline until 30 days after last dose of SBO-154 or longer if required
次要结局
- 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)(From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154)
- 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)(From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154)
- 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)(From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154)
- 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)(From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154)
- To evaluate the progression-free survival (i.e., the time from treatment start to the time of PD or death, per RECIST v1.1)(From baseline to end of trial, at intervals of 6-12 weeks after the first dose of SBO-154)
- Incidences of ADA, titer and neutralizing antibodies(Survival Follow-up: Upto 1 yr)
研究者
Dr Sandeep Inamdar
Sun Pharma Advanced Research Limited
研究点 (3)
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