招募中 NCT06997497

Calderasib ( MK-1084 )靶向治療和化療在結直腸癌患者中的臨床研究( MK-1084-012/KANDLELIT-012 )

大腸直腸癌肉瘤Phase IIIIII 期IV 期KRAS

研究人員正在尋找其他方法來治療局部晚期或轉移性大腸直腸癌( mCRC ) ,該癌症是不可切除的,並具有稱為KRAS G12C的基因突變。 這種類型的結直腸癌的標準(或常規)治療可能包括mFOLFOX6 ±貝伐珠單抗。 研究人員希望了解在mFOLFOX6中添加calderasib (研究藥物)和西妥昔單抗是否可以治療KRAS G12C突變的局部晚期或mCRC。

適應症:Colon Adenocarcinoma、Rectal Adenocarcinoma

收案條件

納入條件

  • Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \[AJCC\] eighth edition) colorectal adenocarcinoma
  • Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period
  • Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

排除條件

  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy
  • Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
  • Has active infection requiring systemic therapy
  • Has not adequately recovered from major surgery or have ongoing surgical complications
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

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。