MC# 20-17 - A Phase I, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of T3011 in Advanced Cutaneous or Subcutaneous Malignancies

  • Agent(s): T3011
  • Disease Type(s): Solid Tumor
  • Phase(s): I
  • Drug Classification(s): Viral Therapy
  • Molecular Target(s): n/a

Mechanism of Action

T3011 is a genetically modified, attenuated oncolytic herpes simplex viruses.


In this study, the sponsor and investigators want to learn:

  • About the safety and tolerability of T3011
  • How proteins that indicate the status of your disease are affected with use of T3011
  • If T3011 prevents or delays tumor growth or shrinks existing tumors
  • How much of T3011 is absorbed into the blood and how fast it is removed from the blood
Inclusion Criteria
  1. Age 18 years or older
  2. Diagnosis
    1. Phase 1 -Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy
    2. Phase 2a Part 1
      1. Arm A - Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic melanoma.  Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
      2. Arm B - Histologically or pathologically confirmed diagnosis of advanced or metastatic solid tumor, excluding metastatic melanoma
    3. Phase 2a Part 2
      1. Histologically or pathologically confirmed diagnosis of NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement (unless participants had progression on prior tyrosine kinase inhibitor therapy).  Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
  3. Disease progression after SOC therapy or in the opinion of the Investigator unlikely to benefit from SOC therapy. SOC may include, but not be limited to chemotherapy, targeted therapy or immunotherapy
  4. Measurable disease per RECIST version 1.1
  5. Must have at least 1 tumor lesion with a longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node lesions) that is accessible for IT injection of T3011 in the opinion of the investigator.  Avoid tumors that are adjacent to major vascular structures and airways.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  7. Life expectancy > 12 weeks
  8. Adequate bone marrow function defined by absolute neutrophil count (ANC) of ≥ 1.5 × 109/L, platelet count of ≥ 100.0 × 109/L, and hemoglobin of ≥ 90 g/L (with or without transfusion)
  9. Adequate hepatic function defined as serum total bilirubin < 2.5 × upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2.5 × ULN (or ≤ 5 × ULN in participants with liver metastases)
  10. Adequate renal function defined as creatinine clearance > 50 mL/min as determined by the Cockcroft-Gault equation
  11. Female participants must be surgically sterile (or have a monogamous partner who is surgically sterile), or be least 2 years postmenopausal, or commit to using 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 6 months following the last dose of study treatment.  Male participants must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 6 months following the last dose of study treatment.
  12. Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening within 14 days of dosing with T3011 and a negative urine pregnancy test pre-dose on W1D1
  13. Last dose of previous anticancer therapy ≥ 21 days, radiotherapy > 21 days (concurrent targeted palliative radiotherapy is allowed to non-injected lesions during T3011 treatment), or major surgery > 21 days prior to the first dose of T3011 or last dose of therapy with tyrosine kinase inhibitors within 5 times
    the half-life of the inhibitor prior to first dose of study treatment.  Last dose of checkpoint inhibitor ≥ 14 days, as long as treatment related toxicities resolve to ≤ Grade 1.
  14. Resolution of all prior anticancer therapy toxicities (except for alopecia) to ≤ Grade 1.  Note: Patients previously treated with immunotherapy who have endocrinopathies may enroll if on adequate replacement therapy.  Patients with toxicities attributed to systemic prior anticancer therapy, which are not expected to resolve and result in long lasting sequalae, such as neuropathy or ototoxicity after platinum-based therapy, are permitted to enroll.
  15. Willingness to provide pre- and post-treatment fresh tumor biopsy specimens as specified in the Schedule of Assessments.  Participants may be eligible to participate without providing fresh tumor biopsy specimens, following discussion with and approval from the Medical Monitor.
  16. Capable of understanding and complying with protocol requirements
  17. Signed and dated institutional review board/independent ethics committee (IRB/IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed
Exclusion Criteria
  1. Have only tumors with severe fibrosis and therefore not injectable
  2. Patients with injectable tumors impinging upon major airways or blood vessels
  3. Prior treatment with another OV or cellular therapy
  4. Requires continued concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).  Topical use of drugs against HSV are allowed.
  5. Systemic therapy with immunosuppressive agents within 28 days before the start of T3011 treatment; topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed
  6. Live vaccines within 4 weeks of initiation of study treatment.  (Seasonal flu or SARS-CoV-2 vaccines that do not contain live viruses are permitted).
  7. Primary or acquired immunodeficient states (leukemia, lymphoma, human immunodeficiency virus (HIV)/AIDS)
  8. Pregnant or lactating
  9. Prior organ transplantation
  10. Active hepatitis B virus or hepatitis C virus or a positive serological test at Screening within 14 days of dosing with T3011
    1. Positive for hepatitis C virus (HCV) Ab only when HCV RNA positive at Screening
    2. Patients who are HBsAg+ and/or HBcAb+ and have a DNA load < 2000 IU/mL (104 copies/mL) are considered eligible to participate in the study
  11. Active autoimmune disease or medical conditions (e.g., active interstitial lung disease/pneumonitis or eczema, psoriasis, or other clinically significant dermatologic disorders) requiring systemic steriod (> 10 mg/day prednisone or equivalent) or immunosuppressive therapy within 6 months prior to first administration of study treatment (unless agreed otherwise between the Medical Monitor and the Investigator on a case-by-case basis).  Non-systemic corticosteriods (eg. topical, inhaled) are allowed
  12. History of or current central nervous system metastases (brain imaging [eg, by computed tomography (CT) scan, positron emission tomography (PET) scan, magnetic resonance imaging (MRI) scan, etc., per site standards] completed within 3 months of W1D1 [required for all participants])
  13. History of seizure disorders within 6 months of Screening
  14. Active oral or skin herpes lesion at Screening
  15. Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids
  16. Congestive heart failure (> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias
  17. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody or their excipients
  18. Active infection with SARS-CoV-2 virus
  19. Other systemic conditions or organ abnormalities that, in the opinion of the Investigator, may interfere with the conduct and/or interpretation of the current study


  • Dallas, TX - Mary Crowley Cancer Research - Medical City
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Re: MC# 20-17