Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293898
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-22
Brief Title:
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Sponsor:
SystImmune Inc
Organization:
SystImmune Inc
Study Overview
Official Title:
A Phase 1 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The objective of this study is to evaluate the safety tolerability and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors
Detailed Description:
BL-M07D1-ST-101 is a global multi-center Phase 1 study to evaluate the safety tolerability pharmacokinetics and efficacy of BL-M07D1 in participants with HER2 expressing advanced malignant solid tumors
This study will be conducted in three parts dose escalation dose finding and dose expansion Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle
This study will be conducted in three parts dose escalation dose finding and dose expansion Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None