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Brief Title: Neo-adjuvant Treatment for Squamous Cell Carcinoma Using Direct Tumor Injection With RP1.
Official Title: A Phase 1B Study of Intralesional Injection of RP1 in Patients With Resectable Cutaneous SCC
Study ID: NCT05858229
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Rochester Dermatologic Surgery, Victor, New York, United States
Name: Catherine VanHooft, HT
Affiliation: Rochester Dermatologic Surgery
Role: STUDY_DIRECTOR