癌研連線CancerLink
招募中 NCT06884618

一项评估RO7673396在晚期实体瘤受试者中的安全性、耐受性、药物动力学(PK)和初步临床活性的研究，大鼠肉瘤病毒肿瘤基因同源物(RAS)突变

胆道癌肉瘤Phase II 期II 期III 期IV 期

本研究旨在评估RO7673396在伴有RAS突变的晚期实体肿瘤参与者中的安全性和耐受性。本研究包括两个阶段：第1阶段（剂量增加）和第2阶段（剂量扩大）。第1阶段将定义RO7673396的扩张（ RDE ）的推荐剂量。

适应症：Neoplasms

入组条件

纳入标准

  • Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
  • Participants with measurable disease according to RECIST v1.1 assessed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥12 weeks
  • Adequate hematologic and end-organ function
  • Confirmed presence of the RAS mutation(s)

排除标准

  • Current participant or enrollment in another interventional clinical trial
  • Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
  • Known and untreated, or active central nervous system (CNS) metastases
  • Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
  • Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
  • Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
  • Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study
  • A history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, non-infectious ILD/pneumonitis, or current evidence of active pneumonitis or ILD on screening chest CT scan
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Known clinically significant liver disease

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。