A Phase 1, Multicentre, Open-label, Dose-escalation and Expansion Study to Determine a Recommended Phase 2 Dose (RP2D) of DT-9081 in Participants With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Dose escalation: safety assessment
研究概览
简要总结
This is a Phase 1, multicentre, open-label, dose-escalation study to determine a recommended phase 2 dose (RP2D) of DT-9081, followed by an expansion study of DT-9081 in participants with advanced, recurrent or metastatic solid tumours
详细描述
This first-in-human Phase 1, multicentre, open label study is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumours who failed standard of care therapies.
This Phase 1 study consists of 2 parts. The first part is a dose-escalation using a modified 3+3 design with up to 8 dose escalation cohorts at increasing levels. The dose-escalation part aims at determining the recommended phase 2 dose. The second part is an expansion to validate the dose/schedule of administration as well as to assess preliminary efficacy of DT-9081.
Patients will be dosed orally once daily. The schedule might be adjusted in case of toxicities.
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
- •Participants must have a histologically or cytologically confirmed advanced solid tumour that is locally advanced (i.e., not eligible for curative surgery or radiotherapy), recurrent or metastatic, and who have failed or are ineligible for standard of care therapies.
- •Participants must be ≥18 years of age.
- •Participants must have measurable disease per RECIST v1.
- •Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Participants must have adequate organ function.
排除标准
- •Participants using drugs interfering with the COX-2 pathways or prohibited drugs.
- •Participants with unresolved AEs from previous anti-cancer therapies of Grade ≥ 2 with exception of alopecia. Participants with Grade ≤ 2 neuropathy may be eligible.
- •Participants who underwent major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 who have not recovered adequately from any AEs and/or complications from the intervention prior to starting study drug.
- •Participants who have received prior radiotherapy within the last 4 weeks before start of study drug treatment (limited field palliative radiotherapy within 2 weeks).
- •Participants who have already received EP4R antagonist in an investigational trial.
研究组 & 干预措施
DT-9081
Capsule, 25 mg, 50 mg and 100 mg
干预措施: DT-9081 - dose escalation (Drug)
DT-9081
Capsule, 25 mg, 50 mg and 100 mg
干预措施: DT-9081 - expansion (Drug)
结局指标
主要结局
Dose escalation: safety assessment
时间窗: Cycle 1 (28 days)
Number of dose-limiting toxicities (DLTs).
Dose escalation and expansion: safety assessment
时间窗: From the first dose of study drug up to 30 days after the last dose of study drug
Incidence and severity of treatment-emergent AEs (TEAEs) and treatment-related TEAEs.
Dose escalation: recommended phase 2 dose (RP2D)
时间窗: Cycle 1 (28 days)
The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study.
次要结局
- Preliminary anti-tumour activity(From the first dose of study drug until the date of disease progression/recurrence, assessed up to 48 months)
- Dose escalation: maximum tolerated dose (MTD)(Cycle 1 (28 days))
- Maximum plasma concentration (Cmax)(Day 28 for each dose)