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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05010694
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects greater than or equal to 18 years old.
2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
3. Expected survival time ≥12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
6. Have documented disease progression or intolerance after first-line treatment.
Exclusion Criteria:
1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
2. Previous accept with KRAS G12C inhibitor.
3. Uncontrollable general infection.
4. Serious cardiovascular disease.
5. Left ventricular ejection fraction (LVEF) \<50 %.
6. Known history of hypersensitivity to any of the excipients of GH35 tablets
7. Pregnant or nursing (lactating) women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05010694
Study Brief:
Protocol Section:
NCT05010694