Ixovex-1 Single Agent and Combination Therapy
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Have signed an informed consent indicating that the subject is aware of the neoplastic nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 2. Female or male subjects aged ≥18 years (local regulatory requirements should be followed if the legal age of consent for study participation is \>18 years old). 3. Subjects with injectable locally advanced, unresectable, or metastatic solid tumours. 4. In Phase Ia and Phase Ib, all solid tumour types will be accepted. 5. For Phase II, all solid tumour types will be considered with an emphasis on cutaneous squamous cell cancers and head and neck cancers. 6. Subjects with at least 1 measurable tumour (per RECIST 1.1)