A Study of VET3-TGI in Patients With Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
KaliVir Immunotherapeutics
Study ID
NCT06444815
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VET3-TGI — DRUG
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
  • Atezolizumab — DRUG
    anti-pd-L1 antibody

Study Details

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).

Key Dates

Start date
Sep 16, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab [ Time Frame: 108 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Xiomara Menendez, RN
[email protected]
Jacob Thomas, MD (PRINCIPAL_INVESTIGATOR)
UC Irvine HealthOrangeCalifornia92868
Patient Contact
[email protected]
Edward Uchio, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Patient contact
[email protected]
Jaime Merchan, MD (PRINCIPAL_INVESTIGATOR)
Community Health NetworkIndianapolisIndiana46250
Patient Contact
317-621-2627
Bert O'Neil, MD (PRINCIPAL_INVESTIGATOR)
UPMC- Hillman Cancer CenterPittsburghPennsylvania15232
Patient Contact
[email protected]
Yana Najjar, MD (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Minal Barve, MD
[email protected]
972-566-3000
Minal Barve, MD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Patient contact
[email protected]
Siqing Fu, MD, PhD (PRINCIPAL_INVESTIGATOR)

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