A Study of VET3-TGI in Patients With Solid Tumors

Purpose

VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).

Conditions

  • Solid Tumor, Adult
  • Microsatellite Stable Colorectal Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Cervical Cancer
  • Kidney Cancer
  • Renal Cell Carcinoma
  • Melanoma Stage IV
  • Merkel Cell Carcinoma of Skin
  • Mesothelioma
  • Non-small Cell Lung Cancer
  • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Urothelial Carcinoma Bladder
  • Squamous Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Additional Inclusion criteria exist

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). Additional Exclusion criteria exist

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A: VET3-TGI alone intratumoral 		Dose escalation of VET3-TGI alone administered by direct injection into tumor(s) x 4. Booster injections of VET3-TGI are permitted for up to 2 years.
  • Drug: VET3-TGI
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Experimental
Group B: VET3-TGI intratumoral in combination with atezolizumab 		VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group A. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.
  • Drug: VET3-TGI
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
  • Drug: Atezolizumab
    anti-pd-L1 antibody
Experimental
Group C: VET3-TGI alone intravenous 		Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.
  • Drug: VET3-TGI
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Experimental
Group D: VET3-TGI intravenous in combination with atezolizumab 		VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group C. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.
  • Drug: VET3-TGI
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
  • Drug: Atezolizumab
    anti-pd-L1 antibody

Recruiting Locations

USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Xiomara Menendez, RN
Xiomara.Menendez@med.usc.edu

UC Irvine Health
Orange, California 92868
Contact:
Patient Contact
clinops@kalivir.com

University of Miami
Miami, Florida 33136
Contact:
Patient contact
clinops@kalivir.com

Community Health Network
Indianapolis, Indiana 46250
Contact:
Patient Contact
317-621-2627

UPMC- Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Contact:
Patient Contact
clinops@kalivir.com

Mary Crowley Cancer Research
Dallas, Texas 75230
Contact:
Minal Barve, MD
972-566-3000
referral@marycrowley.org

University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Patient contact
ClinOps@KaliVir.com

More Details

Status
Recruiting
Sponsor
KaliVir Immunotherapeutics

Study Contact

Adina Pelusio
+13057722084
clinops@kalivir.com

Detailed Description

VET3-TGI was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. This is a Phase 1 dose escalation (and expansion) study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation has 4 groups: the first group (Group A) will determine the highest tolerated dose of VET3-TGI when injected into tumor(s); the second group (Group C) will determine the highest tolerated dose of VET3-TGI when infused into the vein. The third and fourth groups (Group B and D) will combine VET3-TGI with atezolizumab. These groups will begin at the highest tolerated dose determined in Group B and Group D, respectively. Once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI.