Advanced Solid Tumor Clinical Trial
Official title:
A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0006 as a Single Agent in Patients With Advanced Solid Tumors
This is the first in human study of BL0006, and the primary objective is to evaluate the safety and tolerability of BL0006 as a single agent in patients with advanced solid tumors.
This study consists of two parts: dose-escalation stage and dose-expansion stage. The dose-escalation stage is designed to determine the maximum tolerated dose (MTD) and select recommended Phase 2 dose (RP2D) of BL0006 monotherapy. The dose-expansion stage will be conducted with selected doses to further evaluate the preliminary anti-tumor activity, safety and tolerability. A total of approximately 19~66 patients will be enrolled in the study. Approximately 13-30 patients will be enrolled into dose-escalation of BL0006 . A total of 6~36 patients each with advanced solid tumor will be evaluated in dose-expansion of BL0006. Patients will continue to receive BL0006 as long as they are benefiting from treatment in the investigator's opinion and do not meet any other discontinuation criteria. ;
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