Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290388
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-02-08
Brief Title:
Study of 23ME-01473 in Patients With Advanced Solid Malignancies
Sponsor:
23andMe Inc
Organization:
23andMe Inc
Study Overview
Official Title:
A Phase 12a Multicenter Open-label Dose Escalation and Expansion Study of Intravenously Administered 23ME-01473 in Participants With Advanced Solid Malignancies
Status:
RECRUITING
Status Verified Date:
2024-06
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 a first-in-human open-label study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies
Detailed Description:
This study includes a dose escalation portion to determine the maximum tolerated dose MTD andor the recommended phase 2 dose RP2D to evaluate the clinical activity of 23ME-01473 and further evaluate its safety tolerability pharmacokinetics and pharmacodynamics in participants with solid malignancies
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