NCT05886868

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

A Phase I, International, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of BL0020 as A Single Agent in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Shanghai Best-Link Bioscience, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BL0020	Dose Escalation Stage: BL0020 will be administered via intravenous infusion on days 1 of a 21-days treatment cycle. Dose Expansion Stage: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation Stage.

Timeline

• Start date: 2023-10-24
• Primary completion: 2024-07-01
• Completion: 2025-02-01
• First posted: 2023-06-02
• Last updated: 2023-11-29

Locations

4 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study