癌研連線CancerLink
進行中（不再收案） NCT06360354

評估Anvumetostat聯合其他療法治療晚期胃腸道、膽道或胰臟癌且帶有同型合子甲基硫代腺苷磷酸化酶（MTAP）缺失參與者的研究（MTAPESTRY 103）

胰臟癌膽道癌肉瘤Phase IIII 期IV 期KRAS

本研究旨在確定MTA協同PRMT5抑制劑Anvumetostat聯合其他療法在患有轉移性或局部晚期甲基硫代腺苷磷酸化酶（MTAP）缺失胃腸道、膽道或胰臟癌的成年參與者中的最大耐受劑量（MTD）或推薦聯合劑量。

適應症：Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

收案條件

納入條件

  • Subprotocol B
  • Inclusion:
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
  • Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
  • Homozygous MTAP-deletion.
  • Disease measurable as defined by RECIST v1.1.
  • Adequate organ function as defined in the protocol.
  • Exclusion:
  • Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
  • Radiation therapy within 28 days of first dose.
  • Major surgery within 28 days of first dose of Anvumetostat.

排除條件

  • Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
  • History of solid organ transplantation.
  • Subprotocol C
  • Inclusion:
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
  • Homozygous MTAP-deletion.
  • Rat Sarcoma Viral Oncogene Homolog (RAS) mutation
  • Received at least 1 prior systemic therapy for advanced or metastatic PDAC.
  • Disease measurable as defined by RECIST v1.1.
  • Adequate organ function as defined in the protocol.
  • Exclusion:
  • Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
  • Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
  • History of solid organ transplantation.

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。