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Virus Therapy
Group A: VET3-TGI alone intratumoral for Cervical Cancer (STEALTH-001 Trial)
Phase 1
Waitlist Available
Research Sponsored by KaliVir Immunotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 108 months
Awards & highlights
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 pembrolizumab in patients with solid tumors (STEALTH-001).
Who is the study for?
This trial is for adults with advanced solid tumors who have not responded to, cannot tolerate, or refused standard treatments like targeted therapy, immunotherapy, and chemotherapy. Participants must have at least one tumor that can be safely injected or biopsied and should be in good physical condition (ECOG status 0-1). They need to show proper organ function and agree to follow the study procedures.
What is being tested?
The study tests VET3-TGI, a new oncolytic immunotherapy given directly into the tumor or through the vein. It's being tested alone and alongside pembrolizumab to find safe doses for patients with various types of solid tumors including breast, bladder, cervical cancers among others.
What are the potential side effects?
Since VET3-TGI is new and hasn't been used in humans before, specific side effects are unknown but may include typical reactions related to immunotherapies such as flu-like symptoms, fatigue, allergic reactions or inflammation around the injection site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 108 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~108 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determine the recommended Phase 2 dose
Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with pembrolizumab
Secondary study objectives
Efficacy assessment: Duration of response (DOR)
Efficacy assessment: Progression free survival (PFS)
Efficacy assessment: Time to tumor progression (TTP)
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Group D: VET3-TGI intravenous in combination with pembrolizumabExperimental Treatment2 Interventions
VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group C. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.
Group II: Group C: VET3-TGI alone intravenousExperimental Treatment1 Intervention
Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.
Group III: Group B: VET3-TGI intratumoral in combination with pembrolizumabExperimental Treatment2 Interventions
VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group A. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.
Group IV: Group A: VET3-TGI alone intratumoralExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
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Who is running the clinical trial?
KaliVir ImmunotherapeuticsLead Sponsor
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