Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386146
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
Sponsor:
Jacobio Pharmaceuticals Co Ltd
Organization:
Jacobio Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 12a Multi-Center Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
Status:
RECRUITING
Status Verified Date:
2024-08
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 to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation
Detailed Description:
This study consists of two parts Dose Escalation Phase Phase 1 and Dose Expansion Phase Phase 2a The primary objective of dose escalation is to evaluate the safety and tolerability and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation Dose expansion will further explore JAB-30355s clinical benefit and tolerability in selected dose levels
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