癌研連線CancerLink
招募中 NCT07492680

BMS-986504單一治療和與其他藥物合併治療晚期和/或轉移性實體腫瘤伴純合子MTAP缺失參與者的研究（ MountainTAP-5 ）

非小細胞肺癌肝癌胰臟癌黑色素瘤腦瘤Phase IIIII 期IV 期

這是一項開放標籤、多中心2期研究，評估BMS-986504在MTAP缺失的晚期和/或轉移性實體腫瘤參與者中的作用。該研究包括單一治療組分和組合組分，其中BMS-986504與其他抗癌劑一起服用。試驗將評估BMS-986504單藥和聯合治療方案的安全性、耐受性、藥物動力學、藥效學和初步抗腫瘤活性。

適應症：Solid Tumors

收案條件

納入條件

  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
  • Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
  • Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
  • Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

排除條件

  • Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
  • Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
  • Participants must not have active viral HBV or HCV hepatitis.

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。