Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06608940
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
BC3402 w Tremelimumab Durvalumab STRIDE in Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII Study of BC3402 a Novel Anti-TIM3 Agent in Combination With Tremelimumab Plus Durvalumab STRIDE in Advanced Unresectable Hepatocellular Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety and efficacy of an investigational experimental product called BC3402 This product is considered experimental because it is not approved by the US Food and Drug Administration FDA
Detailed Description:
Brief BackgroundRationale
Hepatocellular carcinoma HCC is the most common liver cancer and the fastest rising cause of cancer-related deaths in the US Immune checkpoint inhibitors ICIs proved to be highly efficacious in HCC and the dual ICIs combination tremelimumab plus durvalumab is a standard front-line treatment for advanced and metastatic HCC However the response rate of the dual ICIs regimen is about 20 and participants invariably progress There is a need for more efficacious treatment
T cell immunoglobulin mucin-3 TIM3 is highly expressed on multiple immune cells and plays a complex role in regulating immune responses and inducing immune tolerance BC3402 is a TIM3 targeting inhibitory humanized IgG4 subtype monoclonal antibody which displays synergistic anti-tumor effects when combined with agents targeting PD1 and CTLA4 in preclinical tumor models as well as in the first in human FIH trial Investigators hypothesize that the co-targeting of TIM3 will significantly increase the anti-tumor efficacy of dual targeting of PD1PDL1 and CTLA4 axes in HCC and thus propose a clinical trial to investigate the efficacy of a novel triplet ICI combination of BC3402 plus the STRIDE regimen in participants with advanced unresectable treatment-naïve HCC
Hepatocellular carcinoma HCC is the most common liver cancer and the fastest rising cause of cancer-related deaths in the US Immune checkpoint inhibitors ICIs proved to be highly efficacious in HCC and the dual ICIs combination tremelimumab plus durvalumab is a standard front-line treatment for advanced and metastatic HCC However the response rate of the dual ICIs regimen is about 20 and participants invariably progress There is a need for more efficacious treatment
T cell immunoglobulin mucin-3 TIM3 is highly expressed on multiple immune cells and plays a complex role in regulating immune responses and inducing immune tolerance BC3402 is a TIM3 targeting inhibitory humanized IgG4 subtype monoclonal antibody which displays synergistic anti-tumor effects when combined with agents targeting PD1 and CTLA4 in preclinical tumor models as well as in the first in human FIH trial Investigators hypothesize that the co-targeting of TIM3 will significantly increase the anti-tumor efficacy of dual targeting of PD1PDL1 and CTLA4 axes in HCC and thus propose a clinical trial to investigate the efficacy of a novel triplet ICI combination of BC3402 plus the STRIDE regimen in participants with advanced unresectable treatment-naïve HCC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None