癌研連線CancerLink
招募中 NCT05208047

(Peak) CGT9486+Sunitinib 對比 Sunitinib 用於胃腸道基質瘤受試者的第三期隨機試驗

膽道癌Phase IIIIII 期IV 期

這是一項 CGT9486 聯合 sunitinib 的第三期、開放標籤、國際、多中心研究。這是一項多部分研究，將納入約 482 名患者。第一部分包含兩項評估：1）在約 20 名已接受至少一線治療的胃腸道基質瘤（GIST）患者中，確認將用於後續部分的 CGT9486 更新配方的劑量；以及 2）評估其潛在

適應症：Advanced Gastrointestinal Stromal Tumors、Metastatic Cancer

收案條件

納入條件

  • Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)
  • Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
  • Subjects must have received the following treatment:
  • DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
  • Part 1b: Treatment with ≥2 prior TKI for GISTs
  • Part 2: Prior treatment with imatinib only
  • GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks
  • Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
  • Eastern Cooperative Oncology Group (ECOG) Status
  • to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
  • to 1 (GIST 1L Substudy)
  • Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

排除條件

  • Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
  • Clinically significant cardiac disease
  • Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
  • Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
  • Any active bleeding excluding hemorrhoidal or gum bleeding
  • Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
  • Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
  • Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)
  • Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)

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。