Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444815
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
A Study of VET3-TGI in Patients With Solid Tumors
Sponsor:
KaliVir Immunotherapeutics
Organization:
KaliVir Immunotherapeutics
Study Overview
Official Title:
A Phase 11b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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:
STEALTH-001
Brief Summary:
VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers VET3-TGI has not been given to human patients yet and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumors called an intratumoral injection or when given intravenously into the vein both alone and in combination with pembrolizumab in patients with solid tumors STEALTH-001
Detailed Description:
VET3-TGI was changed in a laboratory to infect and kill cancer cells leaving healthy cells alone This is a Phase 1 dose escalation and expansion study with VET3-TGI administered by direct injection into tumors or by intravenous infusion The dose escalation has 4 groups the first group Group A will determine the highest tolerated dose of VET3-TGI when injected into tumors the second group Group C will determine the highest tolerated dose of VET3-TGI when infused into the vein The third and fourth groups Group B and D will combine VET3-TGI with pembrolizumab These groups will begin at the highest tolerated dose determined in Group B and Group D respectively
Once the highest tolerated dose is found for each of these groups that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI
Once the highest tolerated dose is found for each of these groups that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI
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