Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589596
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1ab Study Investigating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of BGB-58067 an MTA-Cooperative PRMT5 Inhibitor in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 is an open-label multicenter first-in-human dose escalation and dose expansion study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary antitumor activity of BGB-58067 as monotherapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase MTAP deficiency
Detailed Description:
BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 PRMT5 This protein is involved in many cell activities and can promote cancer growth when it is overactive High levels of PRMT5 are linked to poor outcomes in several types of cancer
This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is This drug will be tested as monotherapy in participants with advanced solid tumors and with MTAP deficiency
This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is This drug will be tested as monotherapy in participants with advanced solid tumors and with MTAP deficiency
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