Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

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 \[solid tumors\] 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 tumor, recurrent tumor, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration.
• ✕. Female patients who:
• ✕. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
• ✕. Female patients who are: