Spots Global Cancer Trial Database for RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma
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Trial Identification
Brief Title: RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma
Official Title: A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With Relapsed/Refractory HPV-16 E6/E7 Positive Tumors and Melanoma
Study ID: NCT04762225
Interventions
Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability of escalating doses of RPTR-168 as a monotherapy in patients with HPV-16 E6/E7 positive tumors (HNSCC, cervical) and melanoma.
Detailed Description: This is a phase 1/2, open-label, first-in-human, multi-center study to characterize the safety and tolerability of RPTR-168 administered i.v. as a monotherapy in patients with relapsed/refractory metastatic or locally-advanced HPV-16 E6/E7 positive tumors and melanoma. The study will include 2 dosing periods: A Dose Escalation (Phase 1) followed by an Expansion (Phase 2).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth Research Institute, Scottsdale, Arizona, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Carolina BioOncology Institute, Huntersville, North Carolina, United States
Contact Details
Name: David Spriggs, MD
Affiliation: Repertoire Immune Medicines
Role: STUDY_DIRECTOR
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