Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 12:08 PM
Study NCT ID:
NCT06247657
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Assess the Safety and Tolerability of BL0006 for Patients With Advanced Solid Tumours
Sponsor:
Shanghai Best-Link Bioscience, LLC
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: