Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533332
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-Human Phase 1 Safety Tolerability Pharmacokinetic and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies
Detailed Description:
The goal of this open-label dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors who have progressed on prior approved systemic therapies Participants will receive ERX-315 as an intravenous IV injection twice a week over 21-day cycles
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