A Study to Investigate the Safety of SYHA1815 in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •The previous anti-tumor or surgical treatment history with any of the following conditions:
• •1. Received the treatment of other intervention clinical studies with 4 weeks before the first dose of study drug;
• •2. Had undergone major surgery within 4 weeks before the first dose of study drug or had not fully recovered from any previous invasive operation;
• •3. Prior treatment of RET/FGFR inhibitors or small molecular kinase inhibitors with RET/FGFR as the main targets;
• •Any unresolved toxicities from prior anti-tumor therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1, except for alopecia, pigmentation, previous chemotherapy-related neurotoxicity (≤ grade 2) and other adverse reactions judged no safety risk by the investigators;
• •Subjects with symptomatic brain metastasis or meningeal metastasis, spinal cord compression or mental disorder, and asymptomatic brain metastasis can be enrolled (there is no disease progress within at least 4 weeks after radiotherapy and/or no neurological symptoms after surgical resection, and glucocorticoids, anticonvulsant drugs and mannitol are not required);
• •Impaired cardiac function or clinically significant cardiovascular and cerebrovascular diseases, including any of the following:
• •1. History of myocardial infarction, congestive heart failure (NYHA grade ≥ grade III), and unstable angina pectoris within 6 months prior to screening;
• •2. Cerebrovascular disease occurred within 6 months before screening (except for transient ischemic attack (TIA), lacunar infarction with no clinical significance);
• •3. Severe uncontrollable arrhythmia requiring medical treatment;
• •4. Electrocardiogram (ECG) examination, female QTc interval\>470 milliseconds (ms), male QTc interval\>450 milliseconds (ms) according to Fridericia formula;
• •5. The left ventricular ejection fraction is less than 50% according to cardiac ultrasound examination;
• •History of active bleeding within 6 months before screening;
• •Any serious or uncontrollable disease, and not suitable for this study as determined by the investigator;
• •Any uncontrollable active infection that will prevent the subjects from receiving the study drug within 2 weeks prior to the first dose of study drug;
• •HIV positive, HCV positive with HCV RNA quantity higher than the upper limit of normal value in the research center;
• •Active hepatitis B infection, with the HBV DNA quantity higher than the upper limit of normal value of the research center;
• •A history of any other malignant tumors within 5 years (except for effectively controlled non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past 5 years;
• •Subjects who have taken potent inhibitors and inducers of CYP3A4 liver metabolic enzymes within 2 weeks before the first administration and still need to continue to use such drugs;
• •Women who are breastfeeding;
• •Concomitant disease or condition that may interfere with the conduct of the trial, or that would pose an unacceptable risk to the subject in this trial in the opinion of the investigator.