2025-523684-38-00招募中3 期
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 79
研究概览
简要总结
To compare the overall survival (OS) between participants treated with ASP3082 plus mFOLFIRINOX or NALIRIFOX vs placebo plus mFOLFIRINOX or NALIRIFOX
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically confirmed metastatic PDAC with documented KRAS G12D mutation based on local or central testing (a participant’s positive KRAS G12D mutation status result must be available prior to randomization).
- •Participant has no option for surgical resection or radiotherapy with curative intent.
- •Participant has KRAS G12D mutation from a tissue sample, based on local or central testing
- •Participant has an ECOG PS of 0 or 1 within 7 days prior to randomization.
- •Participant has adequate organ function
排除标准
- •Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous/adenosquamous features
- •Participant has known low or absent DPD activity.
- •Participant has homozygous UGT1A1 polymorphism
- •Participant has received any radiotherapy within 14 days prior to the start of study intervention
- •Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses [i.e., 28 days; 1 cycle] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received [neo]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the [neo]adjuvant therapy).
- •Participant has had prior treatment with a KRAS G12D-targeted agent.
研究组 & 干预措施
Dextrose 5% in water solution for infusion
Placebo
干预措施: Dextrose 5% in water solution for infusion (Drug)
ASP3082
Test
干预措施: ASP3082 (Drug)
研究者
Clinical Trial Unit Head
Scientific
Astellas Pharma Global Development Inc.
研究点 (79)
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