Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
Study NCT ID:
NCT05508659
Status:
UNKNOWN
Last Update Posted:
2022-08-19
First Post:
2022-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Multi-centre, Randomized, Open-label, Phase 1/2 Trial to Investigate the Safety, Tolerability, and Preliminary Anti-cancer Efficacy of Duvelisib Combined With SG001 Injection in Advanced Solid Tumours
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_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:
Study will be conducted with 2 stages.
Detailed Description:
The first stage will explore the suitable dose of duvelisib when combined with SG001 injection in patients with advanced solid tumors who had failed with prior systemic therapy.
The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.
The second stage will explore the safety and tolerability, preliminary anti-tumor efficacy and PK data of duvelisib monotherapy and combo regime with SG001 injection in patients with advanced solid tumors which will including but not limited with esophageal carcinoma, gastric carcinoma, colorectal cancer and head and neck squamous carcinoma.
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?:
False
Is an FDA AA801 Violation?: