Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576037
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Phase Ib Study of CBP-1019 in Combination With FOLFOX - Bevacizumab Pembrolizumab or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase Ib Study of CBP-1019 in Combination With FOLFOX - Bevacizumab Pembrolizumab or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
An open-label Phase Ib dose escalation and dose expansion clinical trial evaluating the safety and efficacy of CBP-1019 combinations in patients with solid tumors of epithelial origin
Detailed Description:
Primary Objectives
To determine the safety and tolerability of CBP-1019 combinations Regimen A CBP-1019 plus FOLFOX Regimen B CBP-1019 plus FOLFOX with bevacizumab Regimen C CBP-1019 plus pembrolizumab and Regimen D CBP-1019 plus enzalutamide in metastatic solid tumors of epithelial origin
To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin
Secondary Objective
To evaluate other indicators of the antitumor activity of CBP-1019 combinations
Exploratory Objectives
To explore potential biomarkers associated with responseresistance and major clinical outcomes toxicity and antitumor activities through molecular profiling at the DNA RNA and protein levels
To explore patient-reported outcomes PROs
To determine the safety and tolerability of CBP-1019 combinations Regimen A CBP-1019 plus FOLFOX Regimen B CBP-1019 plus FOLFOX with bevacizumab Regimen C CBP-1019 plus pembrolizumab and Regimen D CBP-1019 plus enzalutamide in metastatic solid tumors of epithelial origin
To determine the ORR of CBP-1019 combinations in selected metastatic solid tumors of epithelial origin
Secondary Objective
To evaluate other indicators of the antitumor activity of CBP-1019 combinations
Exploratory Objectives
To explore potential biomarkers associated with responseresistance and major clinical outcomes toxicity and antitumor activities through molecular profiling at the DNA RNA and protein levels
To explore patient-reported outcomes PROs
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