NCT07659782招募中2 期
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 16
- 主要终点
- Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
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 Non-Small Cell Lung 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 unresectable locally advanced or metastatic NSCLC
- •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
- •Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.
- •Have documented disease progression during or following their most recent prior line of therapy.
- •Patients with 2L/3L on stable or preferred dose:
- •Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
- •Patients with 2L-4L with brain metastases:
- •Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
- •Have asymptomatic and untreated brain metastases
- •At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.
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
- •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 Monotherapy 2L/3L
Experimental
2L/3L VS-7375 dose
干预措施: VS-7375 (Drug)
VS-7375 Monotherapy 2L/3L Preferred Dose
Experimental
2L/3L Preferred VS-7375 dose
干预措施: VS-7375 (Drug)
2L-4L with brain metastasis
Experimental
2L-4L VS-7375 dose
干预措施: VS-7375 (Drug)
结局指标
主要结局
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
时间窗: 6 months
Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)
To characterize the safety and tolerability of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC
时间窗: 6 months
Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations
次要结局
- Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments(24 months)
- Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax(20 weeks)
- Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC(20 weeks)
- To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type(Up to 2.5 years)
- To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30)(24 months)
- Time to next therapy(24 months)
研究者
研究点 (16)
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