A Phase 1/2, Open-Label, First-in-Human Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumour Activity of ODM-216 in Participants With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
研究概览
简要总结
A Phase 1/2, Open-Label, First-in-Human Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumour Activity of ODM-216 in Participants With Advanced Solid Tumours
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
- •Key Eligibility Requirements.
- •A participant must:
- •Understand the trial procedures and agree to participate by giving written, signed, and dated informed consent (IC; or witness consent).
- •Male or female participants ≥18 years old.
- •Have a performance status of 0 or 1 on the ECOG performance scale.
- •Participants must be willing and able to undergo a baseline tumour biopsy; for further information please refer to protocol.
- •6. Participants must have a histologically or cytologically confirmed advanced solid malignancy and be refractory to or intolerant to established standard of care therapies known to provide clinical benefit as determined by the investigator.
- •7. Participants must have measurable disease per RECIST v1.1, including at least one lesion that is measurable and appropriate for response evaluation. Lesions within a previously irradiated field are permissible as measurable disease provided that clear radiologic progression has been demonstrated and accurate measurement is feasible.
- •8. Refer to the protocol for the full list of inclusion criteria
排除标准
- •Received prior chemotherapy, targeted therapy, or treatment with an investigational anticancer agent within 21 days; or immunotherapy or definitive/curative intent radiation therapy within 28 days, before receiving their first dose of ODM-
- •Have an autoimmune disease that has required systemic treatment in the past 2 years (i.e. use of disease modifying agents, high dose corticosteroids, or immunosuppressive drugs).
- •Brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the first dose of trial treatment. These should be previously treated and shown to be stable for at least 3 months post treatment.
- •Refer to the protocol for the full list of exclusion criteria
研究组 & 干预措施
ODM-216
ODM-216
干预措施: ODM-216 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
时间窗: 8 days
To evaluate the safety and tolerability of ODM-216 to determine the maximum tolerated dose (MTD) if applicable or maximum feasible dose (MFD) if applicable.
Incidence of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events, and clinical laboratory abnormalities (including electrocardiogram [ECG]).
时间窗: 22 months
To identify one or two recommended Part 2 doses (RP2Ds) for subsequent confirmation as the optimal biological dose (OBD) in Part 2.
次要结局
未报告次要终点