Clinical Trial 23549

• Overview

  Study Title:

  A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination with Atezolizumab in Patients with Advanced Solid Tumors

  Objective:

  Primary Objectives: * Evaluate the safety and tolerability of VET3-TGI alone and in combination with pembrolizumab when administered via ITu injection or IV infusion * Establish the recommended Phase 2 dose and define the MTD or MFD of VET3-TGI alone and in combination with pembrolizumab when administered via ITu injection or IV infusion Secondary Objectives: * Determine overall response rate (ORR), disease control rate (DCR), time to progression (TTP), progression free survival (PFS), and duration of response (DoR) as assessed by a central radiologist per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST) * Evaluate overall survival across all arms * Assess VET3-TGI tumor infection, replication, and transgene expression in peripheral blood and tumor tissue * Determine overall survival

• Treatments

  Therapies:

  Immunotherapy; Oncolytic Virotherapy

  Medications:

  Atezolizumab (Tecentriq); VET3-TGI ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
  • Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
  • Measurable disease as per RECIST 1.1 criteria
  • At least one tumor amenable to safe ITu injections and/or biopsies
  • ECOG performance status 0 or 1
  • Demonstrate adequate organ function
  • Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions

• Exclusion Criteria

  Key Exclusion Criteria:
  • Prior systemic therapy washout (dependent upon the therapy)
  • Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
  • CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
  • Prior history of myocarditis
  • Known HIV/AIDS, active HBV or HCV infection.
  • Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).

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