Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549946
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Ixovex-1 Single Agent and Combination Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Open-label Clinical Trial of Intratumoural Ixovex-1 as Single Agent Therapy or in Combination With Pembrolizumab in Palpable Solid Tumours
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:
IXACT
Brief Summary:
This is an open-label dose de-escalating non-randomised multi-centre phase III study to determine safety and efficacy of the oncolytic virus Ixovex-1 administered by intratumoural IT injection This will be assessed in patients with palpable locally advanced unresectable or metastatic tumours for whom all approved therapeutic options have been exhausted are not available are unlikely to have significant clinical benefit or are declined by the patient
Detailed Description:
The Phase Ia arm of the study will employ a modified 33 dose de-escalation design At least six subjects will receive intratumoural injections of Ixovex-1 approximately every 2 weeks over a period of 8 weeks 4 treatments to determine the maximum tolerated dose MTD
The Phase Ib arm of the study will also employ a modified 33 dose de-escalation design At least six subjects will be treated with Ixovex-1 MTD from Phase Ia in combination with standard dosing of Pembrolizumab to determine the recommended phase 2 dose RP2D for the combination therapy Subjects will receive a total of 4 doses of Ixovex-1 and 8 doses of Pembrolizumab Two treatments of Ixovex-1 will be given prior to commencing Pembrolizumab and 2 treatments will be given in combination with the first 2 Pembrolizumab standard infusions administered every 3 weeks The subsequent 6 doses of Pembrolizumab will be administered without Ixovex-1 every 3 weeks thereafter
The Phase II arm of the study will use a Simon Type II study design to assess the RP2D of Ixovex-1 in combination with Pembrolizumab as determined in Phase Ib This will initially involve 6 subjects with the potential to expand to 18 subjects in specific tumor types where clinical benefit or a positive treatment response is observed such as in subjects who have previously been refractory to immunotherapy
The Phase Ib arm of the study will also employ a modified 33 dose de-escalation design At least six subjects will be treated with Ixovex-1 MTD from Phase Ia in combination with standard dosing of Pembrolizumab to determine the recommended phase 2 dose RP2D for the combination therapy Subjects will receive a total of 4 doses of Ixovex-1 and 8 doses of Pembrolizumab Two treatments of Ixovex-1 will be given prior to commencing Pembrolizumab and 2 treatments will be given in combination with the first 2 Pembrolizumab standard infusions administered every 3 weeks The subsequent 6 doses of Pembrolizumab will be administered without Ixovex-1 every 3 weeks thereafter
The Phase II arm of the study will use a Simon Type II study design to assess the RP2D of Ixovex-1 in combination with Pembrolizumab as determined in Phase Ib This will initially involve 6 subjects with the potential to expand to 18 subjects in specific tumor types where clinical benefit or a positive treatment response is observed such as in subjects who have previously been refractory to immunotherapy
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