癌研連線CancerLink
招募中 NCT06884618

一項評估RO7673396在晚期實體瘤受試者中的安全性、耐受性、藥物動力學(PK)和初步臨床活性的研究，大鼠肉瘤病毒腫瘤基因同源物(RAS)突變

膽道癌肉瘤Phase II 期II 期III 期IV 期

本研究旨在評估RO7673396在伴有RAS突變的晚期實體腫瘤參與者中的安全性和耐受性。本研究包括兩個階段：第1階段（劑量增加）和第2階段（劑量擴大）。第1階段將定義RO7673396的擴張（ RDE ）的推薦劑量。

適應症：Neoplasms

收案條件

納入條件

  • 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)

排除條件

  • 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

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。