NCT07659795招募中2 期
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 17
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 or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal 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 metastatic CRC
- •Measurable disease per RECIST 1.1
- •Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
- •ECOG PS=0 or 1
- •2L+ patients:
- •Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma
- •Have documented disease progression during or following their most recent prior line of therapy
- •Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy.
- •1L patients:
- •Treatment-naïve or received no more than 1 cycle of standard systemic therapy 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
- •Receipt of prior direct RAS inhibitor
- •Receipt of more than 1 investigational therapy
- •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 Monotherapy or Preferred Combination in 2L+ CRC
Experimental
Participants randomized to a treatment in 2:1 ratio
干预措施: VS-7375 (Drug)
VS-7375 with chosen regimen in 2L+ CRC
Experimental
干预措施: panitumumab (Drug)
VS-7375 Monotherapy or Preferred Combination in 2L+ CRC
Experimental
Participants randomized to a treatment in 2:1 ratio
干预措施: panitumumab (Drug)
VS-7375 with chosen regimen in 2L+ CRC
Experimental
干预措施: VS-7375 (Drug)
VS-7375 Monotherapy or Preferred Combination in 2L+ CRC
Experimental
Participants randomized to a treatment in 2:1 ratio
干预措施: cetuximab (Drug)
VS-7375 with chosen regimen in 2L+ CRC
Experimental
干预措施: cetuximab (Drug)
VS-7375 + cetuximab and mFOLFOX in 1L CRC
Experimental
干预措施: Cetuximab + mFOLFOX6 (Drug)
研究者
研究点 (17)
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