NCT07644559招募中2 期
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 29
研究概览
简要总结
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Histopathology confirmed PDAC
- •Measurable disease per RECIST 1.1
- •Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
- •ECOG PS=0 or 1
- •Adequate organ function
- •VS-7375 + cetuximab (2L PDAC) :
- •Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months
- •VS-7375 + cetuximab (1L PDAC) :
- •Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease
排除标准
- •Have any other documented co-existing common RAS mutation(s)
- •Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
- •Major surgery within 4 weeks of first treatment dose
- •Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose
- •History of drug-induced Interstitial Lung Disease
- •Receipt of prior direct RAS inhibitor
- •Untreated or symptomatic CNS metastasis
- •Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
- •Receipt of PPI or H2 blocker within 5 days
- •Inability to swallow oral medication
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
VS-7375 + cetuximab 2L PDAC
Experimental
干预措施: VS-7375 (Drug)
VS-7375 Monotherapy
Experimental
干预措施: VS-7375 (Drug)
VS-7375 + cetuximab 1L PDAC
Experimental
干预措施: cetuximab (Drug)
VS-7375 + cetuximab 2L PDAC
Experimental
干预措施: cetuximab (Drug)
VS-7375 + cetuximab 1L PDAC
Experimental
干预措施: VS-7375 (Drug)
研究者
研究点 (29)
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