Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04616443
Status:
RECRUITING
Last Update Posted:
2023-01-31
First Post:
2020-08-31
Brief Title:
OH2 Injection in Combination With HX008 for Melanoma
Sponsor:
Binhui Biopharmaceutical Co Ltd
Organization:
Binhui Biopharmaceutical Co Ltd
Study Overview
Official Title:
Phase Ib Study of the Combination Use of Recombinant Human GM-CSF Type II Herpes Simplex Virus OH2 Injection Vero Cells and HX008 Injection in the Treatment of Melanoma
Status:
RECRUITING
Status Verified Date:
2023-01
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 phase Ib study evaluates the safety and efficacy of OH2 in combination with HX008 an anti-PD-1 antibody in patients with Melanoma
OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52 allowing the virus to selectively replicate in tumors Meanwhile the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor GM-CSF may induce a more potent antitumor immune response
OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52 allowing the virus to selectively replicate in tumors Meanwhile the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor GM-CSF may induce a more potent antitumor immune response
Detailed Description:
The trial is a phase Ib study evaluating the safety and efficacy of OH2 injection combined with HX008 injection in patients with Melanoma
In the Phase Ib dose escalation trial two doses 1x10e6 1x10e7 CCID50mL of OH2 will be combined with HX008at a fixed dose of 200mg will be tested
In the Phase Ib dose expansion trial OH21x10e7 CCID50mL will be injected individually in the first week followed by every two weeks while HX008200 mg will be injected every three weeks after the first injection which will be in the second week
Blood samples will be collected and radiological imaging will be performed to evaluate safety and efficacy during the trial Besides patients will be subjected to cutaneous swabs and bloodurinefeces sampling to determine virus shedding Participating patients will be evaluated for objective response rate progression free survival and overall survival
In the Phase Ib dose escalation trial two doses 1x10e6 1x10e7 CCID50mL of OH2 will be combined with HX008at a fixed dose of 200mg will be tested
In the Phase Ib dose expansion trial OH21x10e7 CCID50mL will be injected individually in the first week followed by every two weeks while HX008200 mg will be injected every three weeks after the first injection which will be in the second week
Blood samples will be collected and radiological imaging will be performed to evaluate safety and efficacy during the trial Besides patients will be subjected to cutaneous swabs and bloodurinefeces sampling to determine virus shedding Participating patients will be evaluated for objective response rate progression free survival and overall survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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