A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC
This is a Phase 1b, single-center, open-label study, evaluating efficacy and safety of RP1 for the treatment of resectable cutaneous Squamous Cell Carcinoma in up to 12 evaluable patients. In this study, patients will receive RP1 via direct intratumoral (IT) injection into superficial cutaneous solid tumors to assess the safety and tolerability as well efficacy of RP1 treatment. The primary efficacy population is up to 12 evaluable patients with resectable CSCC. The enrollment of patients with CSCC will determine study duration.
• Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol.
• Male or female ≥ 18 years of age on the day of signed informed consent.
• Patients must be treatment naïve in the target lesion(s).
• Patients for whom surgical treatment of lesions is clinically indicated.
• At least one measurable histologically confirmed cutaneous tumor of ≥ 1.0 cm in longest diameter and ≤ 3.0 cm with clinically visible residual tumor. More than one tumor may be treated including newly diagnosed lesions.
• ECOG performance status ≤ 1.
• Adequate hepatic function, including both of the following:
• Adequate hematologic function
• Adequate coagulation parameters, including both of the following:
• Anticipated life expectancy \> 2 years
• Have provided either formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained within four months prior to enrollment, with an associated pathology report,. Biopsy can be either by punch or shave method.. A fresh biopsy is required at screening if an archival biopsy (within four months prior to enrollment) is not available.