NCT06247657

A Phase I Study to Assess the Safety and Tolerability of BL0006 for Patients With Advanced Solid Tumours

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

• Status: Recruiting
• 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 BL0006, and the primary objective is to evaluate the safety and tolerability of BL0006 as a single agent in patients with advanced solid tumors.

Detailed description

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BL0006	Patients will be administered BL0006 via intravenous infusion at the corresponding dose level on days 1 and 8 of a 21-days treatment cycle.

Timeline

• Start date: 2024-01-03
• Primary completion: 2024-10-01
• Completion: 2025-05-01
• First posted: 2024-02-08
• Last updated: 2024-04-03

Locations

2 sites across 1 country: China