研究人员正在寻找更好的方法来治疗晚期大肠癌患者。 结肠直肠癌(结肠或直肠癌)是全球最常见的癌症之一。 治疗包括手术、化疗、放射治疗和免疫治疗;然而,这些治疗并不适用于所有人,可能导致严重不良事件或最终可能停止工作。
适应症:Colorectal Adenocarcinoma
入组条件
纳入标准
- 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
排除标准
- 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
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。