Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gregory Daniels, MD
Photo of Gregory Daniels
Gregory Daniels

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Cancer Melanoma (Skin) Mismatch Repair Deficiency Microsatellite Instability Non-melanoma Skin Cancer Cutaneous Melanoma NSCLC Oncolytic virus Oncolytic Immuno-gene therapy Anti-PD1 failed Melanoma Skin Neoplasms Nivolumab Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors Dose expansion of RP1 and nivolumab (IV) in superficial tumors Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors RP1 (IT) and nivolumab (IV) in melanoma RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors RP1 (IT) and nivolumab (IV) in NMSC

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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
  • Have a predicted life expectancy of ≥ 3 months
  • Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
  • Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
  • Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol) for whom anti-PD1/PD-L1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
  • Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
  • Subjects with anti-PD1 failed NSCLC: has confirmed progressive disease after no more than two prior systemic treatments including anti-PD1/PD-L1 treatment

You CAN'T join if...

  • Prior treatment with an oncolytic therapy
  • History of viral infections according to the protocol
  • Prior complications with herpes infections
  • Chronic use of anti-virals
  • Uncontrolled/untreated brain metastasis
  • History of interstitial lung disease
  • History of non-infectious pneumonitis
  • History of clinically significant cardiovascular disease

Locations

  • UC San Diego accepting new patients
    La Jolla California 92093 United States
  • University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UCSD

  • Gregory Daniels, MD
    Clinical Professor, Medicine. Authored (or co-authored) 63 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Replimune Inc.
ID
NCT03767348
Phase
Phase 2
Study Type
Interventional
Last Updated