進行中(不再收案) NCT06333951

Anvumetostat 單藥或與其他治療聯合用於同型合子 MTAP 缺失晚期胸腔腫瘤受試者(主方案)(MTAPESTRY 104)

非小細胞肺癌Phase IIII 期IV 期KRASPD-L1

本研究旨在確定 MTA 協同 PRMT5 抑制劑 Anvumetostat 與其他治療聯合用於患有轉移性或局部晚期甲基硫代腺苷磷酸化酶(MTAP)缺失胸腔腫瘤的成年受試者時的最大耐受劑量(MTD)或推薦聯合劑量。

適應症:Thoracic Tumors、Non-small Cell Lung Cancer

收案條件

納入條件

  • Subprotocol A, B, and C
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing.
  • Homozygous MTAP-deletion
  • Able to swallow and retain PO administered study treatment.
  • Disease measurable as defined by RECIST v1.1.
  • Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.
  • Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab):
  • \- Predominantly squamous histology.
  • Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab):
  • \- Predominantly non-squamous histology.
  • Arm C (Anvumetostat + pembrolizumab):
  • \- PD-L1 positive.
  • Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
  • Subprotocol C
  • Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
  • Brain lesion meeting RANO-BM criteria for measurable disease.

排除條件

  • Subprotocol A, B, and C
  • 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 transplant.
  • Major surgery within 28 days of first dose of Anvumetostat.
  • Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
  • Radiation therapy within 28 days of first dose.
  • Subprotocol A
  • \- Autoimmune disease or immunodeficiency disease as defined in the protocol'

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。