3767348
Last Update Posted: 2025-01-24
Recruiting
All Genders accepted | 18 Years + |
340 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) 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.
Eligibility
Relevant conditions:
Cancer
Melanoma (Skin)
Mismatch Repair Deficiency
Microsatellite Instability
Non-melanoma Skin Cancer
Cutaneous Melanoma
NSCLC
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Contact Information
Overall Contact
Clinical Trials at Replimune
Clinicaltrials@replimune.com
1-781-222-9570
Data sourced from ClinicalTrials.gov