Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391918
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-19
Brief Title:
Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors
Sponsor:
GenVivo Inc
Organization:
GenVivo Inc
Study Overview
Official Title:
A Phase 1 Study of GEN2 in Adult Patients With Locally Advanced or Metastatic Solid Tumor Malignancies
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Protocol GVO-1102 is a phase 1 open label multi-center study in adult patients with locally advanced or metastatic solid tumors This study includes two parts dose escalation and dose expansion In the dose escalation phase GEN2 will be administered at increasing dose levels via intravenous infusion on Days 1 3 and 8 every 4 weeks Valganciclovir will start dosing on Day 12 and continue for 10 days through Day 21 Once a recommended dose has been defined in approximately 40-50 patients the dose expansion phase will initiate Approximately 15 patients per tumor type will be enrolled in the dose expansion phase
Detailed Description:
GEN2 is a non-replicating off-the-shelf gene therapy vector product being developed as a cancer immunotherapy to activate a patients immune system against their personal cancer antigens neoantigens The vector payload encodes for a suicide gene an enhanced viral thymidine kinase enzyme HSV-eTK which in the presence of a prodrug valganciclovir causes the tumor to release patient specific tumor antigens These neoantigens in the presence of a human immune modulator cytokine granulocyte-macrophage colony-stimulating factor hGM-CSF results in the generation of immune effector cells These effector cells maintain continually amplifying therapeutic immune responses as more tumor cells are killed and release antigen and will potentially kill any new tumor metastases that arise
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