Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504381
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
DB107-RRV DB107-FC and Radiation Therapy With or Without Temozolomide TMZ for High Grade Glioma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIa Study to Evaluate the Efficacy of DB107-RRV Formerly Toca511 Administered to Subjects at Time of Resection and Intravenously Thereafter in Combination With DB107-FC Formerly Toca FC and Radiation Therapy or DB107-FC Temozolomide TMZ and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 multicenter open-label study of DB107-RRV formerly Toca 511 and DB107-FC formerly Toca FC when administered following surgical resection in newly diagnosed High Grade Glioma HGG patients The study is designed to evaluate whether treatment with DB107-RRV in combination with DB107-FC when added to standard of care provides clinical benefit to newly diagnosed HGG when compared to historical performance previously determined in well controlled clinical trials published in the peer reviewed literature This study is going to be conducted in newly diagnosed HGG patients receiving with maximum surgical resection treatment followed by radiation and temozolomide treatment using the established Stupp Protocol for O6-methylguanine-DNA methyl-transferase MGMT methylated patients or radiation therapy for MGMT unmethylated patients
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and tolerability of DB107-RRV administered intracranially followed by intravenous IV DB107-RRV and DB107-FC Phase I
II To determine the median progression-free survival PFS informed by biomarker status DGM7 and patient subsets to minimally include genomic profile and histology of newly diagnosed HGG patients treated with DB107-RRV combined with DB107-FC delivered with standard of care following tumor resection Phase IIa
SECONDARY OBJECTIVES
I To confirm the recommended Phase 2 Dose RP2D of DB107-RRV and DB107-FC when administered to newly diagnosed HGG patients Phase I
II To evaluate radiographic response by Immunotherapy response assessment in neuro-oncology iRANO Phase I
III To assess best overall response rates complete response CR partial response PR stable disease SD progressive disease PD and overall response rate CR and PR of each arm and subset Phase IIa
IV To assess the duration of response of each arm and subset Phase IIa V To assess the median overall PFS and PFS at month 6 PFS-6 for each arm and subset Phase IIa
VI To assess the median overall survival of each arm and subset Phase IIa VII To evaluate the safety of DB107-RRV administered intracranially followed by IV DB107-RRV and DB107-FC Phase IIa
OUTLINE
Participants will initially be enrolled in Phase I and treated with DB107-RRV intracranially at time of surgical resection and intravenously within 8 hours following surgery Pathology will be performed locally as per standard practice to confirm participants HGG diagnosis and Isocitrate dehydrogenase 1 IDH1 mutation status Participants in Phase I will then be assigned to one of 2 cohorts No MGMT methylation MGMT unmethylated which will receive DB107-FC and RT following DB107-RRV or Low-High MGMT methylated which will receive DB107-FC Temozolomide TMZ and RT following DB107-RRV The safety and tolerability will be examined for the Phase I participants and RP2D dose confirmed New participants will then be enrolled in Phase IIa under the established RP2D determined in Phase I with the first 2 participants receiving a safety run-in at the RP2D Once participant safety and tolerability are confirmed additional participants will be enrolled in the Phase IIa portion of the study All participants who receive DB107-RRV and DB107-FC will be followed for up to15 years
I To evaluate the safety and tolerability of DB107-RRV administered intracranially followed by intravenous IV DB107-RRV and DB107-FC Phase I
II To determine the median progression-free survival PFS informed by biomarker status DGM7 and patient subsets to minimally include genomic profile and histology of newly diagnosed HGG patients treated with DB107-RRV combined with DB107-FC delivered with standard of care following tumor resection Phase IIa
SECONDARY OBJECTIVES
I To confirm the recommended Phase 2 Dose RP2D of DB107-RRV and DB107-FC when administered to newly diagnosed HGG patients Phase I
II To evaluate radiographic response by Immunotherapy response assessment in neuro-oncology iRANO Phase I
III To assess best overall response rates complete response CR partial response PR stable disease SD progressive disease PD and overall response rate CR and PR of each arm and subset Phase IIa
IV To assess the duration of response of each arm and subset Phase IIa V To assess the median overall PFS and PFS at month 6 PFS-6 for each arm and subset Phase IIa
VI To assess the median overall survival of each arm and subset Phase IIa VII To evaluate the safety of DB107-RRV administered intracranially followed by IV DB107-RRV and DB107-FC Phase IIa
OUTLINE
Participants will initially be enrolled in Phase I and treated with DB107-RRV intracranially at time of surgical resection and intravenously within 8 hours following surgery Pathology will be performed locally as per standard practice to confirm participants HGG diagnosis and Isocitrate dehydrogenase 1 IDH1 mutation status Participants in Phase I will then be assigned to one of 2 cohorts No MGMT methylation MGMT unmethylated which will receive DB107-FC and RT following DB107-RRV or Low-High MGMT methylated which will receive DB107-FC Temozolomide TMZ and RT following DB107-RRV The safety and tolerability will be examined for the Phase I participants and RP2D dose confirmed New participants will then be enrolled in Phase IIa under the established RP2D determined in Phase I with the first 2 participants receiving a safety run-in at the RP2D Once participant safety and tolerability are confirmed additional participants will be enrolled in the Phase IIa portion of the study All participants who receive DB107-RRV and DB107-FC will be followed for up to15 years
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