Overview
This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.
Description
PM1003 is a Bispecific Antibody Targeting PD-L1 and 4-1BB.
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;
- Subjects with malignant tumor confirmed by histology or cytology;
- Adequate organ function;
- ECOG score was 0-1.
- Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication;
- Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.
Exclusion Criteria:
- History of severe allergic to macromolecular protein drugs, severe allergy to drugs or known allergy to any component of the drug in this study;
- Treatment with any 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune co-stimulatory molecule agonist;
- Current active infection requiring intravenous anti-infective therapy;
- Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
- Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- History of neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc.;
- Anticipated need for any other form of antineoplastic drug treatment during the trial;
- Women who are pregnant or breastfeeding;
- Other conditions lead to inappropriate to participate in this study as judged by the investigator.