癌研連線CancerLink
招募中 NCT05208047

(Peak) CGT9486+Sunitinib 对比 Sunitinib 用于胃肠道基质瘤受试者的第三期随机试验

胆道癌Phase IIIIII 期IV 期

这是一项 CGT9486 联合 sunitinib 的第三期、开放标签、国际、多中心研究。这是一项多部分研究，将纳入约 482 名患者。第一部分包含两项评估：1）在约 20 名已接受至少一线治疗的胃肠道基质瘤（GIST）患者中，确认将用于后续部分的 CGT9486 更新配方的剂量；以及 2）评估其潜在

适应症：Advanced Gastrointestinal Stromal Tumors、Metastatic Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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)

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。