PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

Subjects who have central nervous system metastasis with clinical symptoms (e.g., brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. However, subjects who have received prior treatment for brain or meningeal metastases can be included if they have remained stable clinically for at least 2 months and systemic hormone therapy (prednisone at a dose of > 10 mg/day or other hormone at an equivalent dose) has been discontinued for more than 4 weeks;

Subjects who fail to recover from adverse reactions of prior therapies to ≤ CTCAE V5.0 Grade 1. (Patients with residual alopecia, chromatosis and peripheral neurotoxicity that has recovered to ≤ CTCAE Grade 2, and with long-term toxicity caused by radiotherapy that cannot recover as judged by the investigator may be included);

Subjects with systemic diseases that have not been stably controlled after treatment, such as history of severe cardiovascular and cerebrovascular diseases, diabetes mellitus, hypertension, etc.;

Subjects who have any active auto-immune disease or evidence of auto-immune disease, or systemic syndrome previously requiring treatment with systemic steroids or immunosuppressive drugs. (Patients with inactive vitiligo, psoriasis and post-treatment childhood asthma/atopy within 2 years, or thyroid disease that has been controlled with alternative therapy/non-immunosuppression may be included);