Solid Tumor
Conditions
Interventions
A1:BAT1306 1mg/kg
A2:BAT1306 3mg/kg
A3:BAT1306 10mg/kg
Dose expansion:BAT1306
Sponsors
The First Bethune Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) life expectancy = 5 months; 2) aged between 18 and 70 years, male and female; 3) Histological or cytological diagnosis of advanced or metastatic solid tumor; 4) has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1); 5) ECOG performance status of 0 or 1.
Exclusion criteria
Exclusion criteria: 1) Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug; 2) Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years; 3) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 4) Had prior treatment of anti-PD-1,anti-PD-L1 or CTLA-4; 5) had last administration of chemotherapy therapy,radioactive therapy or biological therapy less than 4 weeks prior to the first dose of study therapy BAT1306.has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the anti-tumor treatment; 6) receiving or expected to receive any anti-cancer treatment during the study; 7) patients with autoimmune diseases; 8) Requiring of immunosuppressive systemic steroid therapy; 9) Patients have Interstitial Lung Disease,or pneumonia needing ongoing treatment; 10) Has an active infection requiring systematic therapy; 11) Is positive for Human Immunodeficiency Virus (HIV) or syphilis infection; 12) Has active Tuberculosis; 13) Has known active Hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability;pk; | — |
Secondary
| Measure | Time frame |
|---|---|
| immunogenicity;anti-cancer activities;Receptor Occupancy; | — |
Countries
China
Contacts
Public ContactZhaohe Wang
Bio-thera Solutions, Ltd.
Outcome results
None listed