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Virus Therapy

VET3-TGI + Pembrolizumab for Solid Tumors (STEALTH-001 Trial)

Phase 1

Recruiting

Research Sponsored by KaliVir Immunotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors including preferred indications such as 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

ECOG performance status 0 or 1

Must not have

Known HIV/AIDS, active HBV or HCV infection

Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 108 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new cancer treatment called VET3-TGI in patients with advanced cancer. The study will determine the safe and effective dose of VET3-TGI when injected directly into

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and is one of the specified types.

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I am fully active or can carry out light work.

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I cannot or will not use standard cancer treatments like targeted therapy, immunotherapy, or chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV/AIDS, or active hepatitis B or C.

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I need blood-thinning medication that can't be stopped for certain medical procedures.

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My cancer has spread to my brain or its coverings and hasn't been fully removed or treated with radiation.

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I am on high dose immunosuppressants or have a significant immunodeficiency.

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I have had myocarditis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 108 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~108 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 months for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 3

~3150

0 / 8Eligibility criteria met