Phase I Study of BL0020, a Novel Anti-tumor Drug, in Adult Subjects With Advanced Solid Tumors

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, "3+ 3" will be 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.

Timeline

Start

2023-10-24

Primary completion

2024-07

Completion

2025-02

Drugs

Indications