RecruitingPhase 1Phase 2NCT06549946

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


Sponsor

Psivac Ltd

Enrollment

18 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase trial testing a new drug called Ixovex-1, given either alone or in combination with other therapies, for people with solid tumors (cancers that form in organs or tissues, rather than the blood). Ixovex-1 is injected directly into the tumor. The study is mainly focused on safety and finding the right dosage. **You may be eligible if...** - You are 18 years of age or older - You have a solid tumor that is locally advanced, unresectable (cannot be surgically removed), or has spread (metastatic) - Your tumor can be reached for direct injection - You have tried standard therapies and they have not worked or are not available - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - Your tumor is not accessible for injection - You have serious infections or autoimmune diseases - You have had recent major surgery or are currently receiving certain other therapies that would conflict - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIxovex-1

Ixovex-1 is a novel oncolytic human adenovirus serotype 5.

BIOLOGICALPembrolizumab

Humanised antibody


Locations(1)

The Royal Marsden

London, United Kingdom

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NCT06549946


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