OncoMatch/Clinical Trials/NCT06549946
Ixovex-1 Single Agent and Combination Therapy
Is NCT06549946 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Ixovex-1 and Pembrolizumab for solid tumor.
Treatment: Ixovex-1 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: all approved therapeutic options exhausted, not available, unlikely to have significant clinical benefit or declined
All approved therapeutic options have been exhausted, are not available, are unlikely to have significant clinical benefit or have been declined by the subject.
Cannot have received: oncolytic virotherapy
Previous treatment with oncolytic virotherapy.
Cannot have received: chemotherapy
Received prior chemotherapy within 21 days of C1D1.
Cannot have received: major surgery
Exception: mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery
Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
Cannot have received: biologic therapy
Did not recover from prior biologic therapy, endocrine therapy, or any prior diagnostic or therapeutic procedures.
Cannot have received: endocrine therapy
Did not recover from prior biologic therapy, endocrine therapy, or any prior diagnostic or therapeutic procedures.
Lab requirements
Blood counts
White blood cell counts greater than 3,000/mm3 OR absolute neutrophil counts greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Haemoglobin greater than 9 g/dL (transfusions allowed if not used solely to meet eligibility criteria)
Kidney function
Creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min
Liver function
Aspartate aminotransferase/alanine aminotransferase less than 2.5 times ULN; Bilirubin no greater than 1.5 times ULN
Cardiac function
Left ventricular ejection fraction <50% as determined by MUGA or ECHO, clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥2), uncontrolled hypertension, or clinically significant arrhythmia; Acute myocardial infarction or unstable angina pectoris <6 months prior to study entry
Subject having laboratory values defined as: White blood cell counts greater than 3,000/mm3 OR absolute neutrophil counts greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Haemoglobin greater than 9 g/dL (transfusions allowed if not used solely to meet eligibility criteria); Aspartate aminotransferase/alanine aminotransferase less than 2.5 times ULN; Bilirubin no greater than 1.5 times ULN; Creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min. Impaired cardiac function or clinically significant cardiac disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association Grade ≥2), left ventricular ejection fraction <50% as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO), uncontrolled hypertension, or clinically significant arrhythmia. Acute myocardial infarction or unstable angina pectoris <6 months prior to study entry.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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