招募中 NCT07811193

一項評估VVD-133214與Pembrolizumab聯合治療與Pembrolizumab單獨治療在晚期結腸或直腸癌參與者中的療效的研究

大腸直腸癌Phase IIIII 期IV 期PD-L1MSI

研究人員正在尋找更好的方法來治療晚期大腸癌患者。 結腸直腸癌(結腸或直腸癌)是全球最常見的癌症之一。 治療包括手術、化療、放射治療和免疫治療;然而,這些治療並不適用於所有人,可能導致嚴重不良事件或最終可能停止工作。

適應症:Colorectal Adenocarcinoma

收案條件

納入條件

  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1
  • Have a known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard of care (SoC), and have histologically or cytologically documented advanced (unresectable and/or metastatic) colorectal adenocarcinoma (CRC)
  • No prior systemic treatment for metastatic disease and not amenable to curative resection
  • Participants must have documented MSI and/or dMMR tumor status determined as part of the routine diagnostic workup in a certified laboratory
  • Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor/central laboratory for retrospective central testing including a copy of a redacted pathology report if available
  • Presence of measurable disease according to RECIST v1.1
  • Adequate hematologic and end-organ function, defined using laboratory results obtained within 14 days prior to first dose of study treatment
  • Females of childbearing potential must have negative serum pregnancy test before starting study treatment

排除條件

  • Prior systemic treatment for advanced CRC. Participants may have received prior adjuvant chemotherapy as long as disease progression occurred at least 12 months after the last dose of adjuvant treatment
  • Prior treatment with adjuvant immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents, etc.)
  • Known active or uncontrolled central nervous system (CNS) or brain metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and/or carcinomatous meningitis
  • Patients with active or history of autoimmune disease or immune deficiency that has required treatment in past 2 years
  • History of malignancy other than CRC, within 5 years prior to screening. Participants with Lynch syndrome are not excluded.
  • Participants requiring treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • Participants with active hepatitis B, hepatitis C or HIV
  • Participants with known Werner Syndrome (WRN)
  • Prior treatment with any WRN helicase inhibitor

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。