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A Study of VET3-TGI in Patients With Solid Tumors

NCT06444815 · KaliVir Immunotherapeutics
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Official title
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
About this study
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.
Eligibility 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 Additional Inclusion criteria exist 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). Additional Exclusion criteria exist
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-16
Estimated completion: 2027-12-31
Last updated: 2026-04-07
Interventions
Drug: VET3-TGIDrug: Atezolizumab
Primary outcomes
  • Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab (108 months)
  • Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab (4 weeks)
  • Determine the recommended Phase 2 dose (4 weeks)
Sponsor
KaliVir Immunotherapeutics · industry
Contacts & investigators
ContactAdina Pelusio · contact · clinops@kalivir.com · +13057722084
ContactJames Burke, MD · contact · clinops@kalivir.com
All locations (7)
USC/Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
UC Irvine HealthRecruiting
Orange, California, United States
University of MiamiRecruiting
Miami, Florida, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
UPMC- Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States