Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587479
Status:
UNKNOWN
Last Update Posted:
2022-03-14
First Post:
2020-10-09
Brief Title:
A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
Sponsor:
Jacobio Pharmaceuticals Co Ltd
Organization:
Jacobio Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase 1 Multi-Center Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Subjects With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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 Phase 1 first-in-human open-label study of JAB-8263 to determine the maximum tolerated dose MTD recommended Phase 2 dose RP2D and assess the DLT 30 subjects with advanced solid tumor will be enrolled
Detailed Description:
JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal BET proteins
The objectives of this study are
To determine the maximum-tolerated dose MTD and assess the dose-limiting toxicity DLT of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic PK parameters and pharmacodynamics PDc To evaluate preliminary antitumor activity of JAB-8263
The objectives of this study are
To determine the maximum-tolerated dose MTD and assess the dose-limiting toxicity DLT of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic PK parameters and pharmacodynamics PDc To evaluate preliminary antitumor activity of JAB-8263
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