Overview
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.
Eligibility
Inclusion Criteria:
- Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- Male or female aged 18 to 75 years;
- Patients with malignant tumor confirmed by histology or cytology;
- The toxicity of previous anti-tumor therapy has not been alleviated;
- Adequate organ function;
- ECOG score was 0-1;
- Expected survival >=12 weeks;
- According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.
Exclusion Criteria:
- History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- Evidence of major coagulopathy or other obvious risk of bleeding;
- Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
- Patients with uncontrolled brain metastases should be excluded from this clinical trial;
- Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
- Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- Syphilis antibody positive;
- Patients with active tuberculosis (TB) are excluded;
- Pregnant or lactating women;
- Other conditions lead to inappropriate to participate in this study as judged by the investigator.