Rpl-003-19 An Open-Label, Multicenter, Phase 1B Study Of Rp1 In Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (Cscc)
Posted Date: Aug 3, 2021
- Investigator: Trisha Wise-Draper
- Specialties: Cancer, Oncology
- Type of Study: Drug
The purpose of this study will be to investigate the safety and tolerability of RP1 for the treatment of advanced CSCC in up to 30 evaluable organ transplant recipients. This will include patients with either previous renal or hepatic allograft transplantation and experiencing subsequent documented locally advanced or metastatic CSCC. The experimental arm will receive RP1 administered as an intra-tumoral injection every 2 weeks. Efficacy will be measured by the amount of serious adverse events.
Criteria:
Patients With Histologically Or Cytologically Confirmed Recurrent, Locally Advanced Or Metastatic (To Skin, Soft Tissue Or Lymph Nodes) Cutaneous Squamous Cell Carcinoma, Who Have Progressed Following Local Resection Or One Local (I.E., Topical) Medical Therapy. Patients Who Are Renal Or Hepatic Organ Allograft Recipients On A Stable Immunosuppressive Regimen For At Least 12 Months Prior To Study Participation With Stable Renal And/Or Hepatic Function. At Least 1 Lesion That Is Measurable And Injectable By Study Criteria (Tumor Of =1Cm In Longest Diameter Or =1.5 Cm In Shortest Diameter For Lymph Nodes). Ecog Performance Status =1. Anticipated Life Expectancy > 6 Months. Baseline Ecg Without Evidence Of Acute Ischemia. No Prior Systemic Anti-Cancer Treatment For Cscc. No Patients With Visceral Metastases. No Patients With Active Herpetic Infections Or Prior Complications Of Hsv-1 Infection. No Patients With A History Of Organ Graft Rejection Within 12 Months. No Patients With An Anc < 1.0 X 109/L At Any Point Within 3 Months Of Starting Therapy. No Patients Requiring Ctla-4-Ig Medications.
Keywords:
Phase 1
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com