Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Katy Tsai, MD
Photo 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) Melanoma, Uveal Melanoma, Ocular Bladder Cancer Mismatch Repair Deficiency Microsatellite Instability Non-melanoma Skin Cancer Melanoma Skin Neoplasms Nivolumab Dose escalation of RP1 by intratumoral (IT) injection Dose escalation of RP1 by IT injection Dose expansion of RP1 and nivolumab intravenously (IV) Dose expansion of RP1 and nivolumab (IV) RP1 (IT) and nivolumab (IV) in melanoma RP1 (IT) and nivolumab (IV) in bladder cancer RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors RP1 (IT) and nivolumab (IV) in NMSC RP1(IT) and nivo(IV) in anti-PD1 Refractory Cutaneous Melanoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
  • Male or Female ≥ 18 years of age
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • At least one measurable and injectable lesion
  • Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol
  • Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of RP1 or nivolumab
  • WOCBP must agree to use adequate birth control throughout their participation and for 3 months after RP1 alone and 5 months after nivolumab last study treatment
  • Males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 3 months for RP1 alone and 7 months after nivolumab last study treatment

For Subjects in the Combination Treatment

  • Baseline ECG that does not show abnormalities according to the protocol
  • Baseline oxygen saturation levels that do not show abnormalities according to the protocol
  • Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy

For Subjects in Phase 2 only

  • Have a predicted life expectancy of ≥ 3 months
  • Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria,
  • Subjects with melanoma: has Stage IIIb to IV (skin, eye or mucosal) for whom anti PD-1 therapy is indicated or who have previously received an anti-PD-1 therapy, or have refused, become intolerant to or have no further therapy options available
  • Subjects with MSI-H tumors: has diagnosis of MSI-H 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
  • Subject with dMMR tumors: has diagnosis of 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
  • Subject 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 PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
  • Subjects with bladder cancer: diagnosis of locally advanced or metastatic bladder cancer for whom anti PD-1 therapy is indicated, or have refused, become intolerant to or have no further therapy options available
  • Subjects with cutaneous melanoma, that have confirmed progressive disease after at least 12 weeks of anti-PD1 treatment

You CAN'T join if...

  • Prior treatment with an oncolytic therapy
  • History of viral infections according to the protocol
  • Systemic infection requiring IV antibiotics within 14 days prior to dosing
  • Prior complications with herpes infections
  • Chronic use of anti-virals
  • Systemic therapies for cancer within 4 weeks of first dose (some others may be accepted with shorter time periods)
  • Conditions that require certain doses of steroids (some doses and types will be permitted)
  • Known active brain metastases - previously treated brain metastases may be permitted
  • Prior certain other diagnosis of cancer
  • Is participating in another clinical study or has participated in the past 4 weeks prior to the first dose

Combination Phase Subjects

  • Certain autoimmune diseases, some types will be permitted
  • Allergy or sensitivity to study drug components
  • History of interstitial lung disease
  • History of non-infectious pnuemonitis
  • Other serious or uncontrolled medical disorders

Locations

  • University of California- San Francisco accepting new patients
    San Francisco California 94115 United States
  • Intermountain Cancer Center- Saint George Cancer Center accepting new patients
    Saint George Utah 84790 United States

Lead Scientist at UCSF

  • Katy Tsai, MD
    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 1/2
Study Type
Interventional
Last Updated