Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374173
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-16
Brief Title:
A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally AdvancedMetastatic Solid Tumors
Sponsor:
Hefei TG ImmunoPharma Co Ltd
Organization:
Hefei TG ImmunoPharma Co Ltd
Study Overview
Official Title:
A Phase 1 Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally AdvancedMetastatic Solid Tumors
Detailed Description:
This is a Phase 1 multicenter open-label two-parts FIH study to evaluate the tolerability safety PKPD and preliminary anti-tumor activity of TGI-6 as monotherapy in subjects with unresectable locally advancedmetastatic CRC or subjects with confirmed B7-H6-positive locally advancedmetastatic solid tumors
The study consists of two parts a dose escalation part Phase 1a and a dose expansion part Phase 1b For each subject in the two parts the study will include a screening period up to 28 days a treatment period until treatment discontinuation and a follow-up period including safety and survival follow-up
The study consists of two parts a dose escalation part Phase 1a and a dose expansion part Phase 1b For each subject in the two parts the study will include a screening period up to 28 days a treatment period until treatment discontinuation and a follow-up period including safety and survival follow-up
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