Phase I/IIa First-In-Human Study of EOS884448 in Participants With Advanced Cancers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Percentage of participants with Adverse Events
研究概览
简要总结
IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers.
详细描述
Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with 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
- •Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448
- •Be more than18 years of age on day of signing informed consent.
- •Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available
- •Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated
- •Have an ECOG performance status of Grade 0 to
- •Have adequate organ function.
- •Agree to use adequate contraception during the treatment if required.
排除标准
- •Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose.
- •Has undergone major surgery within 5 weeks before initiating treatment.
- •Has received prior radiotherapy within 2 weeks of start of IP.
- •Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible.
- •Has known CNS metastases.
- •Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids.
- •Has uncontrolled or significant cardiovascular disease.
- •Has received vaccine containing live virus within 4 weeks.
- •Has known active or chronic viral hepatitis.
- •Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.
研究组 & 干预措施
Multiple Ascending Dose
Dose escalation according to cohort allocation
干预措施: EOS884448 (Drug)
结局指标
主要结局
Percentage of participants with Adverse Events
时间窗: From first dose date to 90 days after the last dose (up to 48 weeks)
Define the recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced tumors.
时间窗: up to 48 weeks
Percentage of participants who experience a Dose Limiting Toxicity
时间窗: From first study treatment administration through Day 28
次要结局
- Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level(up to 48 weeks)
- Percentage of participants with Objective Response as determined by Investigator according to RECIST v1.1or per other specific response criteria according to their tumor type.(From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 48 weeks))
- Mean and median Area under the curve (AUC) of EOS884448 at each dose level(up to 48 weeks)
- Percentage of participants with anti-drug antibodies to EOS884448(Recorded at baseline (screening), during the first 4 cycles of treatment (4 months), at end of treatment, and 30 and 90 days post last dose (approximately 48 weeks))