Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257264
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-02-05
Brief Title:
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1a1b Study of BG-68501 a Selective CDK2 Inhibitor in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 study is a first-in-human FIH Phase 1a1b study of BG-68501 a cyclin-dependent kinase-2 inhibitor CDK2i to assess the safety tolerability pharmacokinetics PK pharmacodynamics and preliminary antitumor activity of BG-68501 in participants with advanced nonresectable or metastatic solid tumors The study will also identify a recommended dose for expansion RDFE in subsequent disease directed studies
The study will be conducted in 2 parts Part 1 dose escalation and safety expansion and Part 2 dose expansion
The study will be conducted in 2 parts Part 1 dose escalation and safety expansion and Part 2 dose expansion
Detailed Description:
None
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