This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Sign informed consent before conducting any trial-related activities;
Age of 18-75 years old, male or female;
Patients with first-line treatment failure;
Measurable lesions according to RECIST1.1 criteria.
Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
Known to produce allergic reactions to any component of the trial treatment;
no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
Poorly controlled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions.
Guangzhou FineImmune Biotechnology Co., LTD.
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator