Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSD UCSF
Dates
study started
estimated completion
Principal Investigator
by Gregory Daniels, MD (ucsd)Bartosz Chmielowski, MD (ucla)John Fruehauf, MD (uci)Katy Tsai, MD (ucsf)
Headshot of Gregory Daniels
Gregory Daniels
Headshot of Katy Tsai
Katy Tsai

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, 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
  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • University of California- San Francisco accepting new patients
    San Francisco California 94115 United States
  • University of Southern Californi accepting new patients
    Los Angeles California 90033 United States

Lead Scientists at University of California Health

  • Gregory Daniels, MD (ucsd)
    Dr. Daniels coordinates our clinical program in melanoma. His own research involves understanding the link between autoimmunity and tumor immunity in developing more effective and less toxic vaccines and immune stimulatory approaches for patients with melanoma.
  • Bartosz Chmielowski, MD (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 114 research publications
  • John Fruehauf, MD (uci)
    Recall Faculty, Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences. Authored (or co-authored) 51 research publications
  • Katy Tsai, MD (ucsf)
    Dr. Katy K. Tsai is a medical oncologist and clinical researcher who specializes in treating advanced melanoma and other non-melanoma skin cancers, such as squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma. Dr. Tsai graduated with a degree in comparative literature from Brown University before earning her medical degree from Brown.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Replimune Inc.
ID
NCT03767348
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated