A Phase 1 First-in-Human, Drug-dose Escalation Study of RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced Cutaneous Squamous Cell Carcinoma or With Head and Neck Squamous Cell Carcinoma
A phase 1a/1b, open-label, RM-1995 drug-dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of RM-1995 photoimmunotherapy treatment as monotherapy (phase 1a) or combined with pembrolizumab (phase 1b) in patients with cutaneous squamous cell carcinoma (cuSCC) or head and neck squamous cell carcinoma (HNSCC) that has progressed despite all available standard therapies.
• Patient must be at least 18 years old.
• Patient must have tumor types of head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell carcinoma (cuSCC)
• Locally advanced or locoregional disease that has recurred or progressed on or after at least one prior line of therapy, which must include prior platinum-based chemotherapy, and is not eligible for further locoregional treatment (ie, standard surgery or radiation), or for which locoregional treatment has proved to be intolerable or is medically contraindicated.
• Metastatic disease that has recurred or progressed following prior platinum-based chemotherapy, prior immunotherapy with PD-(L)1 inhibitors, or other standard of care systemic treatment, has proven to be ineffective, intolerable, or is considered medically contraindicated in the opinion of the Investigator
• Patient must have tumors with at least one superficial lesion of the skin or oral cavity, not deeper than 1 cm and that is accessible for photoimmunotherapy treatment. Note: Lesions that are in the pharynx and larynx will not be included in the treatment.
• Patient must have the ability to provide representative tumor specimens with an associated pathology report.
• Patient must have measurable disease by RECIST 1.1 as assessed by Investigator.
• Patient must have ECOG performance status of 0 to 2 at the time of screening
• Patient has life expectancy ≥ 3 months based on Investigator's judgement.
• Adequate organ function laboratory values (Hematology, Hepatic, Renal and Coagulation).
• Female patients of childbearing potential must not be pregnant or breastfeeding and must be willing to use 2 methods of highly effective birth control, or practice abstinence throughout the study and for at least 120 days after the last dose of study medication.
• Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence starting with the first dose of study medication and for at least 120 days after the last dose of study medication.