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 intravenous (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 consent 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