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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05173805
Eligibility Criteria:
Patients must meet all of the following inclusion criteria before they can be enrolled in this trial:
1. Age ≥ 18 years
2. For locally advanced or metastatic malignant solid tumors with KRAS mutations (including p.G12D, p.G12V, p.G12C, p.G12A) confirmed by histology and genomics, patients with KRAS p.G12C mutations are preferentially enrolled.
A. For patients with NSCLC, previous first-line treatment based on platinum failed; B. For patients with colorectal cancer, at least two-line systemic treatment regimens have been experienced previously（Patients with colorectal cancer and high microsatellite instability must receive at least PD-1 or PD-L1 if clinically applicable） C. Patients with solid tumors other than NSCLC or colorectal cancer should have received systematic treatment at least once.
3. According to recist1.1 standard, there are measurable or evaluable tumor lesions
4. performance status，PS≤1
5. Estimated survival time \> 3 months
6. It has a good level of organ function A. Bone marrow function needs to meet：ANC≥1.5×109/L；PLT≥100×109/L；Hb≥9g/dL B. renal function：Cr≤1.5 times the upper limit of normal value；or Creatinine clearance≥50ml/min C. liver function：total bilirubin\<1.5 x ULN（For subjects with documented Gilbert syndrome,\< 2.0 x ULN or subjects with indirect bilirubin levels suggesting a source of extrahepatic elevation\<3.0 x ULN）；ALT and AST≤ 2.5 x ULN（If liver metastasis occurs≤ 5 x ULN） D. Coagulation function：Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x upper normal limit (ULN), or international normalized ratio (INR) \< 1.5 or within the target range (if preventive anticoagulant therapy is performed） E). The corrected QT interval (QTcF) of Fridericia method is less than 450 ms for males and less than 470 ms for females.
7. The elution period of macromolecular drugs is ≥ 4 weeks, and that of oral fluorouracil and small molecule targeted drugs is ≥ 2 weeks
8. Fertile women must have a negative blood pregnancy test within 72 hours before receiving the first study drug;
9. For fertile men and women, they must be willing to use appropriate contraceptive methods 30 days before the first study drug administration and 120 days after the last study drug administration;
10. Did not participate in the clinical trial as a subject within 1 month before participating in the trial;
11. According to the judgment of the researcher, the compliance is high, willing to complete the test and can abide by the test scheme;
12. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent form in writing.
Exclusion criteria
Patients with any of the following items cannot be enrolled in this study:
1. Untreated patients with brain metastasis meet one or more of the following conditions：
1. Need to use corticosteroids or dehydration treatment (except those with treated or asymptomatic brain metastases);
2. There are significant clinical symptoms;
3. The tumor stabilization time after radiotherapy or surgery should not exceed 4 weeks.
(Except for patients with brain metastasis who have been treated or have no symptoms)
2. Other malignant tumors in recent five years. Basal cell carcinoma of the skin, except squamous cell carcinoma of the skin or cervical carcinoma in situ after potential treatment;
3. Myocardial infarction, symptomatic congestive heart failure (New York Heart Association \> grade II), unstable angina pectoris or arrhythmia requiring drug treatment occurred within 6 months before enrollment
4. Have a history of gastrointestinal diseases or gastric surgery or inability to swallow oral drugs
5. Active infection requiring treatment
6. Patients with active hepatitis B (hepatitis B surface antigen and / or hepatitis B core antibody positive and HBV-DNA \> 103 copies /mL or 200IU/mL) or hepatitis C patients (hepatitis C virus positive and / or HCV-RNA positive) or HIV positive patients are required to receive treatment.
7. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first use of the study drug, or elective surgery during the trial, or therapeutic or palliative radiotherapy within 2 weeks before the first use of the study drug
8. Allergic constitution, or known history of allergy to this drug component
9. According to the researchers' judgement, there are serious diseases that may endanger the safety of patients or affect the completion of research, such as uncontrollable hypertension, uncontrollable diabetes and thyroid diseases.
10. There is fluid accumulation in the third space that cannot be controlled by drainage or other methods (such as massive identification and hydrothorax)
11. Have a clear history of neurological or mental disorders
12. The researchers believe that the subjects are not suitable to participate in this study for other reasons
In case of one or more of the following circumstances, the subject shall suspend the test:
1. Subjects asked to withdraw from the study;
2. Imaging evidence shows that the disease is progressing
3. Pregnancy events occurred during the study
4. After dose adjustment, the subject still could not tolerate the toxicity
5. The researcher considers it necessary to withdraw from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05173805
Study Brief:
Protocol Section:
NCT05173805