Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686682
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2020-12-23
Brief Title:
A First-in-Human JAB-8263 in Adult Patients With Advanced Tumors
Sponsor:
Jacobio Pharmaceuticals Co Ltd
Organization:
Jacobio Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Phase IIIa Multi-Center Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2023-03
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 Phase 12a first-in-human open-label study of JAB-8263 this study has two parts solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study
These two parts will determine the maximum tolerated dose MTD recommended Phase 2 dose RP2D and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately 30 subjects each will be enrolled
These two parts will determine the maximum tolerated dose MTD recommended Phase 2 dose RP2D and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately 30 subjects each 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 malignant tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic PK parameters and pharmacodynamics PDcTo 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 malignant tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic PK parameters and pharmacodynamics PDcTo evaluate preliminary antitumor activity of JAB-8263
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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