NCT06549946

Ixovex-1 Single Agent and Combination Therapy

A Phase I/II Open-label, Clinical Trial of Intratumoural Ixovex-1 as Single Agent Therapy or in Combination With Pembrolizumab in Palpable Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Psivac Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose de-escalating, non-randomised, multi-centre phase I/II 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 3+3 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 3+3 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.

Conditions

• Solid Tumor
• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Ixovex-1	Ixovex-1 is a novel oncolytic human adenovirus serotype 5.
BIOLOGICAL	Pembrolizumab	Humanised antibody

Timeline

• Start date: 2024-12-17
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2024-08-12
• Last updated: 2025-01-30

Locations

1 site across 1 country: United Kingdom