NCT06244771招募中1 期
An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants With KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 403
- 试验地点
- 45
- 主要终点
- Dose Limiting Toxicities
研究概览
简要总结
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
- •Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate hematological, renal, and hepatic function
- •Agrees not to participate in another interventional study while receiving study drug
排除标准
- •Leptomeningeal disease or carcinomatous meningitis
- •Clinically significant toxicity resulting from prior cancer therapies
- •Known or suspected hypersensitivity to FMC-376 or any components of the study drug
- •Condition that would interfere with study drug absorption
- •Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
研究组 & 干预措施
FMC-376
Experimental
Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
干预措施: FMC-376 (Drug)
结局指标
主要结局
Dose Limiting Toxicities
时间窗: Up to 21 Days
Number of participants with Dose Limiting Toxicities (DLTs)
Adverse Events (AEs)
时间窗: Approximately 24 Months
Number of participants with treatment-emergent adverse events (TEAEs)
次要结局
- Clearance (CL) of FMC-376 from Blood Plasma(Approximately 24 Months)
- Duration of Response (DOR)(Approximately 24 Months)
- Time to Reach Maximum Blood Concentration (Tmax) of FMC-376(Approximately 24 Months)
- Volume of Distribution (Vd) of FMC-376(Approximately 24 Months)
- Overall Response Rate (ORR)(Approximately 24 Months)
- Disease Control Rate (DCR)(Approximately 24 Months)
- Overall Survival (OS)(Approximately 24 Months)
- Minimum Observed Plasma Concentration (Cmin) of FMC-376(Approximately 24 Months)
- Area Under Blood Concentration-Time Curve (AUC) of FMC-376(Approximately 24 Months)
- Maximum Observed Plasma Concentration (Cmax) of FMC-376(Approximately 24 Months)
- Elimination Half-life (t1/2) of FMC-376(Approximately 24 Months)
- Progression-Free Survival (PFS)(Approximately 24 Months)
研究者
研究点 (45)
Loading locations...
相似试验
进行中（未招募）
1 期
Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT05537987InnoCare Pharma Inc.30
已完成
1 期
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors PatientsAdvanced/Metastatic Solid TumorsNCT04501276Adagene Inc72
招募中
1 期
A First-in-human of Multiplle Doses of BB-1709 in Subjects With Locally Advanced/Metastatic Solid TumorsSolid TumorNCT06241898Bliss Biopharmaceutical (Hangzhou) Co., Ltd300
已完成
1 期
A Study of MK0731 in Patients With Advanced Solid Tumors (0731-002)(COMPLETED)CancerNCT00104364Merck Sharp & Dohme LLC30
终止
1 期
A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsBreast CancerOvarian CancerNon-small Cell Lung CancerNCT04875806NextCure, Inc.40