Possibia

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.

locations

Contact Information

Overall Contact

Clinical Trials at Replimune

Clinicaltrials@replimune.com

1-781-222-9570

Data sourced from ClinicalTrials.gov