Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644300
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Study of BM230 in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Multicenter Non-randomized Open-label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BM230 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Phase I multicenter non-randomized open-label first-in-human study of BM230 conducted globally The study will include two parts a dose escalation part Phase Ia followed by a dose expansion part Phase Ib Phase Ia part will estimate the MTDREDs in dose escalation cohorts of patients with advanced solid tumors HER2-related solid tumors The Phase Ib part will enroll 5 distinct cohorts of patients with advanced solid tumors related to HER2 under MTDRED doses to better define the safety profile of BM230 and evaluate the efficacy of BM230
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None