GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
Sponsored by Suzhou Genhouse Bio Co., Ltd.
About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the participation requirements?
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.