CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia

Exclusion criteria

• ✕. Ability and willingness to comply with the study's visit and assessment schedule.
• ✕. Male or female ≥ 18 years of age at Visit 1 (Screening).
• ✕. Pathologic diagnosis of \[solid tumours\] indicated in the relevant substudy(ies).
• ✕. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• ✕. At least one lesion (primary tumour, recurrent tumour, or effaced metastatic lymph node) ≥ 2 cm in the shortest diameter that is surface accessible for CIVO injection that may be guided by ultrasound if appropriate and for which there is a planned surgical intervention. Treatment plan may include adjuvant radiation or chemotherapy and patients should have no medical contraindication to surgery.
• ✕. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• ✕. Female patients who:
• ✕. Tumours or effaced nodes that are anticipated by the Investigator to lack a sufficient volume of viable tumour tissue (based on available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports) for CIVO injection due to size, location, necrosis, cysts, excessive stroma, fibrosis, or treatment-induced tissue changes.