Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06963502
Eligibility Criteria:
Inclusion Criteria:
* Men or women greater than or equal to 18 years
* At least one measurable lesion in accordance with RECIST 1.1
* Must have an ECOG performance status of 0 or 1.
* Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
* Documentation of the presence of a KRAS G12C mutation
* Estimated life expectancy ≥12 weeks.
* Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.
* The subjects are able to comply with the process of the protocol.
Exclusion Criteria:
* Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
* Active brain metastases.
* Patients with uncontrolled pleural, ascites or pericardial effusion
* Spinal cord compression
* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
* Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
* History of other primary malignancies.
* Inadequate bone marrow reserve or organ functions.
* Abnormal cardiac examination results.
* Severe, uncontrolled or active cardiovascular disorders.
* Diabetes ketoacidosis or hyperglycemia hyperosmolality
* Uncontrolled hypertension.
* Severe bleeding symptoms or bleeding tendencies.
* Severe arteriovenous thrombosis occurred
* Serious infection.
* Continuous use of glucocorticoids
* Active infectious diseases.
* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
* Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
* Interstitial lung disease (ILD).
* Serious neurological or mental disorders.
* Active autoimmune diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06963502
Study Brief:
Protocol Section:
NCT06963502