Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
This is the first in human study of BL0020, and the primary objective is to evaluate the
safety and tolerability, and determine the maximum tolerated dose (MTD) and recommended phase
II dose (RP2D) of BL0020 as a single agent in patients with advanced solid tumors.
This study consists of two parts: Part A (dose escalation stage) and Part B (dose expansion
stage).
The study includes screening, treatment and follow-up periods.
In part A, accelerated titration (the first three dose groups) and "3 + 3" combination (the
subsequent dose group) were used for dose escalation.
In part B, the dose level and/or enrolled patient population for dose-expansion may be
adjusted based on available data on the safety, PK and preliminary efficacy gained from the
patients.