Ignite Creation Date:
2024-05-06 @ 4:26 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04984668
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2021-07-05
Brief Title:
A Phase IbII Study of GT90001 Combined With KN046 in Solid Tumors
Sponsor:
Suzhou Kintor Pharmaceutical Inc
Organization:
Suzhou Kintor Pharmaceutical Inc
Study Overview
Official Title:
A Phase IbII Multicenter Study of GT90001 in Combination With KN046 in Patients With Advanced or Refractory Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Phase Ib is a dose De-escalation study to evaluate the safety tolerability pharmacokinetics PK and preliminary antitumor activity of GT90001 in combination with KN046 in subjects with advanced or refractory hepatocellular carcinoma HCC gastric carcinoma GC and gastroesophageal junction GEJ adenocarcinoma urothelial carcinoma UC and esophageal square cell carcinoma ESCC
Phase II is to investigate anti-tumor efficacy of GT90001 in combination with KN046 at RP2D in subjects with specific types of tumors A Simon two-stage design is planned for each indication in order to minimize the number of treated participants if there is minimal efficacy activity in that indication
Phase II is to investigate anti-tumor efficacy of GT90001 in combination with KN046 at RP2D in subjects with specific types of tumors A Simon two-stage design is planned for each indication in order to minimize the number of treated participants if there is minimal efficacy activity in that indication
Detailed Description:
None
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