JAB-21822 Combined With Chemotherapy and Bevacizumab in Second-line KRAS G12C CRC

Korábbi kezelés

• Patients have received KRAS G12C inhibitors.
• Patients have received a first-line treatment, which include fluoropyrimidine, oxaliplatin and irinotecan.
• Patients who had major surgery or significant trauma within 4 weeks prior to the first blood sample collection during the screening period, or expected to require major surgery during the study period.
• Prior history of interstitial lung disease or non-infectious pneumonia; history of active tuberculosis.

Más betegség

• Patients with active ulcers and gastrointestinal bleeding.
• Patients with other malignancies within five years.

Laborértékek

• Patients with clinically diagnosed autoimmune disease; HIV, HCV positive; HBV-DNA beyond the normal range of the laboratory; Acute CMV infection.

Egyéb

• Patients who are pregnant or breastfeeding.
• Life expectancy of less than 3 months.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Patients with active central nervous system metastases requiring treatment.
• Assessed by the investigator, patients who are unable or unwilling to comply with the requirements of the study protocol.

• Histologically (or cytologically) confirmed, unresectable metastatic colorectal cancer.
• KRAS G12C mutation.
• At least one measurable disease per RECIST v1.1; assessed within 28 days before first dose.
• Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease progression must within three months; first-line chemotherapy regimens do not limit the use of antiangiogenic agents.
• Adequate bone marrow, liver and renal function.
• ECOG performance status 0-1.
• Informed consent has been signed.