RecruitingInterventionalPhase 1

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

NCT ID: NCT06444815Sponsor: KaliVir ImmunotherapeuticsLast updated: 2026-04-07

Summary

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).

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.

Arms & interventions

DrugVET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
DrugAtezolizumab
anti-pd-L1 antibody

Outcome measures

Primary

Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Time frame: 108 months
Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab
Number of dose limiting toxicities, as defined in the protocol, by dose group
Time frame: 4 weeks
Determine the recommended Phase 2 dose
he highest dose of VET3-TGI in each group that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with atezolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation
Time frame: 4 weeks

Secondary

Efficacy assessment: overall response rate (ORR)
Time frame: 108 months
Efficacy assessment: Duration of response (DOR)
Time frame: 108 months
Efficacy assessment: disease control rate (DCR)
Time frame: 108 months
Efficacy assessment: Time to tumor progression (TTP)
Time frame: 108 months
Efficacy assessment: Progression free survival (PFS)
Time frame: 108 months
Overall survival
Time frame: 108 months
Immune changes in tissue and blood
Time frame: 6 weeks
VET3-TGI delivery and replication kinetics
Time frame: 6 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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