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Protocol No. UW18113

Principal Investigator Emamekhoo, Hamid

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

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

Objective The main purpose of this study is to see how well RP1 is tolerated by the body and to determine the safest dose of RP1 for future studies. This study will also test the safety and efficacy of RP1 when it is injected into your tumor on its own as well as in combination with nivolumab for the treatment of certain types of solid tumors. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. It also delivers a substance called GM-CSF, which signals the body's immune system (the immune system defends against disease) to attack the cancer. It has also been changed to add a protein called "GALV" that helps the virus to spread from cell to cell. This will be the first time that RP1 will be used in humans and the purpose of this study is to learn about the safety and good or bad effects it has on you and your cancer. RP1 is not approved for use in the United States of America (USA) by the Food and Drug Administration (FDA) or other international government authorities to treat people with cancer. This investigational drug can only be used in a clinical research study

Treatment RP1 will be injected directly into the tumor through your skin
Nivolumab will be given intravenously every 2 weeks

Description Phase I/II Study with RP1 as Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Key Eligibility
All patients:
  • Male or female at lease 18 years of age on the day of signed informed consent
  • At least one measurable and injectable (including use of image-guided injection) tumor greater than 1 cm in longest diameter (or shortest diameter for lymph nodes)
  • Females of childbearing potential must can not be pregnant
  • Female and Male subjects of childbearing potential must be willing to use a highly effective method of birth control as defined by the protocol
  • Adequate hematologic function, hepatic function, and renal function as defined by the protocol
  • ECOG performance status 0 - 1
    Phase 1 patients only: Patients with histologically or cytologically confirmed advanced or metastatic non neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for which there is no standard therapy preferred to enrollment in a clinical trial Note: there is no limit to the number of prior treatment regimens
    Phase 1 Expansion and Phase 2 patients only: Baseline ECG without evidence of acute ischemia or prolonged QT interval greater than 440 ms in men and greater than 460 ms in women. Baseline troponin less than 0.06 ng/mL. Baseline pulse oximetry greater than or equal to 92% on room air, have provided either a formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tumor tissue sections, obtained within 3 months prior to enrollment, with an associated pathology report, must be submitted to the core laboratory for inclusion. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is unacceptable for submission)
    Phase 2 patients only: Measurable disease based upon RECIST 1.1 as assessed by the local site. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions, Life expectancy of at least 3 months, Patients with melanoma: Diagnosis of stage IIIb-IV melanoma (includes ocular and mucosal(no more than 10 each), LDH less than 1.5 ULN, for whom PD-1 directed therapy is indicated according to a current approved label or who have previously received a PD1/L1 directed therapy (only one prior systemic therapy for metastatic disease, other than adjuvant); Patients must be eligible to receive nivolumab according to product label, or have exhausted or become intolerant to, or refuse, currently available therapies for melanoma
    EXCLUSION:
  • Prior treatment with an oncolytic therapy
  • No known history of Hepatitis B or known active Hepatitis C virus or human immunodeficiency virus (HIV) infection
  • Had systemic infection requiring intravenous (IV) antibiotics or other serious infection within 14 days prior to dosing
  • Requires intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)
  • Major surgery less than or equal to 2 weeks prior to starting study drug
  • Prior malignancy active within the previous 3 years
  • Can not be pregnant or breastfeeding
    Phase 1 Expansion and Phase 2 patients only:
  • Treatment with botanical preparations
  • Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics