A Study of XS-02 Capsules in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Chemotherapy, small molecule targeted therapy, endocrine therapy and traditional Chinese medicine with anti-tumor indications were received within 2 weeks prior to the first dose. Received tumor immunotherapy, antibodies, polypeptide antitumor, or other investigational drugs within 4 weeks prior to initial administration.
• •Patients who had undergone therapeutic surgery other than diagnosis, biopsy, drainage, or radical radiotherapy within 4 weeks prior to initial dosing, or who expected to undergo major surgery during the study period. Had received palliative radiotherapy within 2 weeks prior to the first dose, or had used radiopharma (strontium, samarium, etc.) within 56 days prior to the first dose.
• •The toxicity of previous antitumor therapy has not recovered (\> NCI-CTCAE 5.0 grade 1),alopecia, pigmentation, or other toxicity that the investigators assessed had become chronic and did not affect the safety of the investigational medication returned to NCI-CTCAE 5.0 level 2 or below.
• •Imaging (Computed Tomography(CT) or magnetic resonance imaging(MRI)) shows that the tumor has invaded large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or is at risk of bleeding (such as esophageal and gastric varices).
• •inflammatory breast cancer
• •There is clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention (within 2 weeks prior to administration).
• •Patients with central nervous system metastasis who meet any of the following conditions:
• •1. need to undergo local treatment (surgery, radiation or other);
• •2. Patients who require steroid hormones, anticonvulsants, or other dehydration treatment;
• •3. Only enrollment is allowed Stable symptoms, imaging assessment (imaging evaluation of brain metastases within 4 weeks prior to enrollmentlesions that have not progressed) and do not require treatment
• •Patients with difficulty swallowing, or a history of severe gastrointestinal disease (e.g. active inflammatory bowel disease, gastrointestinal perforation) and related symptoms that cannot be reasonably controlled; Or have a gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, intestinal obstruction, short bowel syndrome) or other malabsorption conditions that affect drug absorption.
• •Have active or unstable cardiovascular disease
• •Bacterial, fungal, or viral infections requiring intravenous antibiotics/antivirals or hospitalization were investigated within 2 weeks prior to initial drug administration.
• •People who have a history of prior severe allergies, or are allergic to any active or inactive ingredient of the investigatory drug.
• •Known acute or active hepatitis B (hepatitis B virus（HBV） surface antigen positive with HBV deoxyribonucleic acid（DNA）≥500 IU/mL), hepatitis C virus infection (HCV Ribonucleic Acid（RNA） exceeding the normal range), syphilis infection, and human immunodeficiency virus (HIV) infection.
• •Other primary malignancies have been diagnosed within the previous five years (the following conditions can be included: cured and completely resected basal and squamous cell skin cancers, completely resected cancers of any type in situ).
• •Use within 2 weeks prior to first administration, or expect to use a Cytochrome P450 enzyme(CYP3A) booster or strong inducer during study drug administration.
• •Use within 2 weeks prior to first administration, or expect to use any drug known to prolong the corrected QT(QTc) interval during study drug administration.
• •The ATR/CHK1 pathway has been treated in the past.
• •Had a bone marrow transplant or had extensive radiation therapy on more than 25% of the bone marrow in the 8 weeks prior to initial dosing.
• •A history of blood clotting disorders; Anticoagulant or antiplatelet therapy (oral aspirin dose ≤100 mg/d and subcutaneous injection of low molecular weight heparin for prevention of deep vein thrombosis) is required.
• •Pregnant and lactating women.
• •According to the judgment of the investigator, any other serious or uncontrolled acute or chronic diseases or abnormal laboratory tests or other reasons are not suitable for participation in this clinical study.