Ignite Creation Date:
2024-05-06 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03556228
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2018-04-29
Brief Title:
Selective TrkA Inhibitor VMD-928 to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Sponsor:
VM Oncology LLC
Organization:
VM Oncology LLC
Study Overview
Official Title:
An Open-Label Multiple-Dose Dose-Escalation Study to Investigate the Safety Pharmacokinetics and Pharmacodynamics of VMD-928 in Subjects with Solid Tumors or Lymphoma
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:
None
Brief Summary:
This is a multicenter open-label Phase 1 study of orally administered VMD-928 in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
Detailed Description:
This is an open-label Phase I FTIH multiple-dose dose-escalation and cohort expansion multi-center study conducted in three parts to identify a safe and pharmacologically active dose and regimen for VMD-928 monotherapy which can be implemented in Phase 2 studies the RP2D The regimen will be identified using an adaptive design multiple-ascending dose study in cancer patients To conserve patients in the lower dose cohorts dose escalation will begin with an accelerated titration scheme A second part of the study will assess antitumor activity at the RP2D The third part of the study will collect tumor samples before and after treatment to assess biological activity
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