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

Launched by JIAN LI · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for advanced colorectal cancer (CRC) that has a specific genetic mutation called KRAS G12C. The trial is looking at how well a drug called JAB-21822 works when combined with standard chemotherapy for patients who have already tried other treatments without success. This research is particularly important for patients in China, as they currently do not have access to some approved treatments available elsewhere.

To be eligible for the trial, patients must have confirmed advanced CRC that cannot be surgically removed, have the KRAS G12C mutation, and have experienced disease progression after their first treatment. Participants should be between the ages of 65 and 74, in good overall health, and able to provide informed consent. Those who join the trial can expect to receive the new treatment alongside standard chemotherapy while being closely monitored for safety and effectiveness. It's an opportunity to contribute to important research that could help improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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• • Subject have withdrawn from the first-line chemotherapy due to disease progression or unacceptable toxicity; if first-line chemotherapy and maintenance therapy were received, disease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.
• Exclusion Criteria:
• • Patients have received KRAS G12C inhibitors.
• • Patients have received a first-line treatment, which include fluoropyrimidine, oxaliplatin and irinotecan.
• • Patients who are pregnant or breastfeeding.
• • Life expectancy of less than 3 months.
• • 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.
• • Patients with active ulcers and gastrointestinal bleeding.
• • Prior history of interstitial lung disease or non-infectious pneumonia; history of active tuberculosis.
• • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• • Patients with clinically diagnosed autoimmune disease; HIV, HCV positive; HBV-DNA beyond the normal range of the laboratory; Acute CMV infection.
• • Patients with active central nervous system metastases requiring treatment.
• • Patients with other malignancies within five years.
• • Assessed by the investigator, patients who are unable or unwilling to comply with the requirements of the study protocol.