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
by Katy Tsai

Description

Summary

This Phase 1B study is a multicenter, open-label, study of RP1 to investigate the safety and tolerability of RP1 for the treatment of advanced CSCC in up to 30 evaluable organ transplant recipients. This will include patients with either previous renal or hepatic allograft transplantation and experiencing subsequent documented locally advanced or metastatic CSCC. The study will enroll a total of 30 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.

Official Title

An Open-Label, Multicenter, Phase 1B Study of RP1 in Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CSCC)

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 1B, open label, multicenter, trial evaluating the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 in adult hepatic and renal transplant recipients who subsequently experienced advanced or metastatic CSCC. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous or nodal tumors. No transplanted organs will be injected.

Keywords

Cutaneous Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell RP1, intra-tumoral injection, oncolytic virus

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
  2. Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous squamous cell carcinoma, who have progressed following local resection or one local (i.e., topical) medical therapy.
  3. Patients who are renal or hepatic organ allograft recipients on a stable immunosuppressive regimen for at least 12 months prior to study participation with stable renal and/or hepatic function. NOTE: Patients who require CTLA-4-Ig medications are excluded.
  4. Patients for whom surgical or radiation treatment of lesions is contraindicated.
  5. At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  7. Anticipated life expectancy > 6 months
  8. Baseline ECG without evidence of acute ischemia.
  9. All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded [FFPE] block or 20 unstained slides).

You CAN'T join if...

  1. Prior treatment with an oncolytic therapy or more than one prior CSCC-directed local/topical therapy.
  2. Prior systemic anti-cancer treatment for CSCC.
  3. Patients with visceral metastases.
  4. Patients with active herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis).
  5. Patients with a history of organ graft rejection within 12 months.
  6. Patients with an ANC < 1.0 x 109/L at any point within 3 months of starting therapy.
  7. Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
  8. Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir) unless for organ allograft preservation.
  9. Patients requiring CTLA-4-Ig medications.
  10. . Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
  11. . Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
  12. . Any history of transplant-related viral infections, such as BK, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
  13. . Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
  14. . Known active CNS metastases and/or carcinomatous meningitis.

Locations

  • UCSF, Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90024 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Replimune Inc.
ID
NCT04349436
Phase
Phase 1
Study Type
Interventional
Last Updated