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Clinical Trial 20533

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04348916

Phase: Phase I
Principal Investigator: Soliman, Hatem

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Study Title

A Phase 1, Open-Label, Multicenter, Dose Escalation and Expansion Study of ONCR-177, an Oncolytic Herpes Simplex Virus for Intratumoral Injection, Alone and in Combination with PD-1 Blockade in Adult Subjects with Advanced and/or Refractory Cutaneous, Subcutaneous or Metastatic Nodal Solid Tumors


This is a phase 1, open-label, multi-center, dose escalation and expansion study of ONCR-177, an oncolytic Herpes Simplex Virus for intratumoral injection, alone and in combination with PD-1 blockade in adult subjects with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.


Primary To assess the safety and tolerability of ONCR-177 alone and in combination with PD-1 blockade To determine the maximum feasible, safe and tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of ONCR-177 for intratumoral injections alone and in combination with PD-1 blockade in subjects with cutaneous, subcutaneous or metastatic nodal tumors



Immunotherapy; Therapy (NOS)


ONCR-177 (); Pembrolizumab (Keytruda)

Inclusion Criteria

  • Male or female > 18 years of age
  • Solid tumor cancer with at least one injectable cutaneous, subcutaneous or nodal tumor
  • Have advanced or metastatic solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or must have a disease for which no standard of care exists
  • Be fully recovered from major surgery and from the acute toxic effects of prior chemotherapy radiotherapy, or immunotherapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • Must have adequate hematologic function in accordance with the study protocol
  • Must have adequate hepatic function in accordance with the study protocol
  • Must have adequate renal function in accordance with the study protocol
  • Female subjects of reproductive potential must have a negative serum pregnancy test during Screening and a serum or urine pregnancy test must be re-confirmed as negative no more than 72 hours before starting study treatment. Females of reproductive potential as well as fertile men with partners who are female of reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent, during the study, and for 6 months (both females and males) following the last dose of study drug(s)
  • Life expectancy of > 3 months
  • Expansion: Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

  • Exclusion Criteria

  • Subjects on current antiviral treatment for herpes virus infections
  • Requires chronic or intermittent treatment with systemic antivirals
  • Any systemic anti-cancer treatment (including investigational agents) within 4 weeks prior to the first dose of study drug
  • Has received prior radiotherapy within 2 weeks of start of study treatment
  • Myelosuppressive chemotherapy within 4 weeks of study treatment
  • Prior checkpoint inhibitor therapy administered within 4 weeks of study treatment
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Has not fully recovered from any effects of major surgery or not free of significant detectable infection
  • Other active malignancy within the previous 3 years of first dose of study treatment
  • Has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
  • Have had significant active cardiac disease within 6 months prior to the start of study treatment
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has received a live vaccine within 30 days prior to the first dose of study drug
  • Are pregnant or breastfeeding

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