2024-515674-27-00招募中1 期
A Phase 1b, Open Label, Dose Escalation Study of IOA-289, an Orally Bioavailable, Selective Autotaxin (ENPP2) Inhibitor Alone and in Combination with Gemcitabine/nab-paclitaxel in Patients with Metastatic Pancreatic Cancer
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- iOnctura SA
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Incidence of treatment-emergent adverse events [Safety and Tolerability]
研究概览
简要总结
The objective of study IOA-289-102 is to evaluate the safety and tolerability of escalating doses of IOA-289 in patients with metastatic pancreatic cancer in combination with standard chemotherapy consisting of gemcitabine and nab-paclitaxel. Blood and tumour samples for PK and PD will be collected and assessments for determination of any clinical efficacy will be completed.
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 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IOA-289 in combination with gemcitabine/nab-paclitaxel
Experimental
干预措施: IOA-289 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events [Safety and Tolerability]
时间窗: Adverse event assessment will be assessed by CTCAE v5.0, through study completion, an average of 1 year.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
次要结局
- Cmax(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- t½(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- AUC0-∞(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- Preliminary efficacy(Imaging for RECIST assessment will start at C2D1 ±3 Days and repeated every 8 Weeks (56 ± 5Days) until disease progression.)
- Cmin(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- CA19-9(for an average of 6 months)
- Overall response rate [ORR](for an average of 6 months)
- Disease control rate [DCR](for an average of 6 months)
- tmax(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- AUC0-t(at Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.)
- BED(for an average of 6 months)
- Duration of response [DOR](for an average of 6 months)
- Progression free survival [PFS](for an average of 6 months)
- LPA(for an average of 6 months)
- Overall survival [OS](for an average of 6 months)
研究者
Michael Lahn
Scientific
iOnctura SA
研究点 (2)
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