Brief Summary
This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS – human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenousinto or within a vein (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advancedat a late stage, far along solid tumors.
Intervention / Treatment
- Biological: CF33-hNIS
- Biological: Pembrolizumab
Inclusion Criteria
- Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. from patient or legally authorized representative
- Age ≥ 18 years old on the date of consent
- Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment)
- ECOG performance status 0 – 2
- At least one measurable lesion
- Adequate renal function
- Adequate liver function
- Adequate hematologic function
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures