Overview
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Eligibility
Inclusion Criteria:
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with unresectable recurrent or metastatic solid tumors;
- There is at least one lesion could be measured;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined;
- Life expectancy ≥3 months.
Exclusion Criteria:
- Patients with known active central nervous system (CNS) metastases;
- Subjects who had other malignancy in five years before the first dose;
- Patients with tumor-related pain that cannot be controlled as determined;
- Patients with serious cardiovascular and cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Patients with Severe infections;
- History of immunodeficiency;
- History of autoimmune diseases;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy
- Active infection;
- Pregnant or nursing women;
- Known history of serious allergic reactions to the investigational product or its main ingredients.