Rpl-001-16 An Open-Label, Multicenter, Phase 1/2 Study Of Rp1 As A Single Agent And In Combination With Pd1 Blockade In Patients With Solid Tumors
Posted Date: Aug 3, 2021
- Investigator: Trisha Wise-Draper
- Specialties: Cancer, Oncology
- Type of Study: Drug
This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy. Efficacy will be determined by the percentage of adverse events, percentage of dose limiting toxicities, percentage of overall response rate, and maximum tolerated dose.
Criteria:
Eastern Cooperative Oncology Group (Ecog) Performance Status Of 0-1. At Least One Measurable And Injectable Lesion. Have Provided A Former Tumor Pathology Specimen Or Be Willing To Supply A New Tumor Sample From A Biopsy. Measurable Disease, According To Response Evaluation Criteria In Solid Tumors (Recist) V1.1 Criteria. No Prior Treatment With An Oncolytic Therapy. No History Of Viral Infections According To The Protocol. No Prior Complications With Herpes Infections. No Chronic Use Of Anti-Virals. No Uncontrolled/Untreated Brain Metastasis. No History Of Interstitial Lung Disease. No History Of Non-Infectious Pneumonitis. No History Of Clinically Significant Cardiovascular Disease.
Keywords:
Phase 1, Solid Tumors
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com