癌研連線CancerLink
进行中（不再招募） NCT06360354

评估Anvumetostat联合其他疗法治疗晚期胃肠道、胆道或胰腺癌且带有同型合子甲基硫代腺苷磷酸化酶（MTAP）缺失参与者的研究（MTAPESTRY 103）

胰腺癌胆道癌肉瘤Phase IIII 期IV 期KRAS

本研究旨在确定MTA协同PRMT5抑制剂Anvumetostat联合其他疗法在患有转移性或局部晚期甲基硫代腺苷磷酸化酶（MTAP）缺失胃肠道、胆道或胰腺癌的成年参与者中的最大耐受剂量（MTD）或推荐联合剂量。

适应症：Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

入组条件

纳入标准

  • 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.

排除标准

  • 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.

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。