Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06549946

Ixovex-1 Single Agent and Combination Therapy

Led by Psivac Ltd · Updated on 2025-01-30

18

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

P

Psivac Ltd

Lead Sponsor

I

IQVIA Biotech

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Ixovex-1 Single Agent and Combination Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to give signed informed consent and comply with study requirements
  • Age 18 years or older (follow local legal age if higher)
  • Have injectable locally advanced, unresectable, or metastatic solid tumors
  • Accept all solid tumor types in Phase Ia and Ib
  • For Phase II, solid tumors considered with focus on cutaneous squamous cell and head and neck cancers
  • Have at least one measurable tumor per RECIST 1.1 suitable for injection
  • Have at least one tumor larger than 1 cm by ultrasound or clinical measurement
  • All approved therapeutic options have been exhausted, unavailable, unlikely to benefit, or declined by subject
  • ECOG performance status of 0 or 1
  • Life expectancy greater than 6 months
  • Pathologically confirmed locally advanced or metastatic solid malignancy
  • Laboratory values within defined limits (WBC >3000/mm3 or ANC >1500/mm3, platelets >100,000/mm3, hemoglobin >9 g/dL, AST/ALT <2.5x ULN, bilirubin ≤1.5x ULN, creatinine clearance ≥50 mL/min)
  • Willing and able to comply with scheduled visits, treatment plan, imaging, and lab tests
Not Eligible

You will not qualify if you...

  • Presence of active or untreated CNS metastases or leptomeningeal disease requiring recent therapy
  • Tumors involving major blood vessels that risk patient safety
  • Significant or uncontrolled cardiac diseases including congestive heart failure (NYHA Grade ≥2), LVEF <50%, uncontrolled hypertension, or arrhythmias
  • Acute myocardial infarction or unstable angina within 6 months prior to study entry
  • Interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis
  • Known immune system disorders including HIV or hepatitis B/C
  • Chronic liver disease or hepatic impairment (Child-Pugh class B or C)
  • Other malignant diseases except certain treated or indolent cancers
  • Receiving systemic chronic steroids (>10 mg/day prednisone or equivalent) or immunosuppressive therapy
  • Use of live vaccines within 4 weeks before study treatment
  • History of stroke or active neurological symptoms affecting assessments
  • Active infections requiring systemic therapy
  • Active cytomegalovirus infection
  • Recent major surgery within 2 weeks prior to first study dose
  • Not recovered from prior biologic, endocrine, or other therapies
  • Prior chemotherapy within 21 days before first dose
  • Previous treatment with oncolytic virotherapy
  • Presence of CTCAE grade 2 or higher toxicity from prior cancer therapy, except certain exclusions
  • Participation in investigational study within 4 weeks or 5 half-lives before first dose
  • Any medical condition preventing safe study participation as judged by investigator
  • Pregnant or breastfeeding; females of childbearing potential and males must use effective contraception
  • Known hypersensitivity to components of Ixovex-1 or Pembrolizumab (latter for Phase Ib and II only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Royal Marsden

London, United Kingdom, SW3 6JJ

Actively Recruiting

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Research Team

I

Imad Mardini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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Ixovex-1 Single Agent and Combination Therapy | DecenTrialz