Clinical Research Directory

Inclusion Criteria: * Willing to participate in the study and provide written informed consent * Age ≥18 years at the time of signing informed consent; no sex restriction * Histologically or cytologically confirmed colorectal cancer (CRC) * KRAS G12D mutation confirmed by the central laboratory * Disease progression or intolerance during or after prior systemic anticancer therapy * At least one measurable lesion * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1 * Investigator-assessed life expectancy ≥12 weeks * Adequate function of major organs * In the investigator's judgment, the participant is able to communicate effectively, adhere to the scheduled follow-up visits, and comply with the protocol requirements Exclusion Criteria: * Other malignancy that has progressed or required treatment within 3 years prior to randomization * Known presence of other actionable/targetable driver gene alterations * Leptomeningeal metastases, spinal cord compression, or active/symptomatic brain metastases * Pleural effusion, ascites, or pericardial effusion requiring repeated puncture/drainage (≥2 times/month) or causing significant symptoms within 28 days prior to randomization * Clinically significant severe cardiovascular disease * Stroke, transient ischemic attack (TIA), or other severe cerebrovascular disease within 6 months prior to randomization * High-risk factors for bleeding or perforation * Concurrent interstitial lung disease, radiation pneumonitis, or immune-mediated pneumonitis that is clinically significant and requires treatment * Major acute or chronic infectious disease * Other poorly controlled systemic disease * Prior targeted therapy against KRAS or RAS * History of organ transplantation or planned organ transplantation * Receipt of a live attenuated vaccine within 28 days prior to randomization, or planned vaccination with a live attenuated vaccine during the trial drug treatment period * Pregnant or lactating women * Any other condition that, in the investigator's judgment, makes the participant unsuitable for study participation