Solid Tumor, AdultPhase 1STEALTH-001NCT06444815
A Study of VET3-TGI in Patients With Solid Tumors
A Phase 1 study testing VET3-TGI and Atezolizumab in people with Solid Tumor, Adult and Microsatellite Stable Colorectal Cancer, run by KaliVir Immunotherapeutics at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Microsatellite Stable Colorectal Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- VET3-TGI and Atezolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Sep 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
James Burke, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
Minal Barve, MD, 972-566-3000, referral@marycrowley.org
Minal Barve, MD
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Patient contact, ClinOps@KaliVir.com
Siqing Fu, MD, PhD
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
Patient Contact, 317-621-2627
Bert O'Neil, MD
- Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Xiomara Menendez, RN, Xiomara.Menendez@med.usc.edu
Jacob Thomas, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Patient contact, clinops@kalivir.com
Jaime Merchan, MD
- Recruiting
UC Irvine Health
Orange, California, 92868
Patient Contact, clinops@kalivir.com
Edward Uchio, MD
- Recruiting
UPMC- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Patient Contact, clinops@kalivir.com
Yana Najjar, MD
About this study
Official title: A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
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).
Read the 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.
- Conditions
- Solid Tumor, Adult, Microsatellite Stable Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer, Kidney Cancer, Renal Cell Carcinoma
- Being tested
- VET3-TGI, Atezolizumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Uterine Cervical Neoplasms, Kidney Neoplasms, Carcinoma, Renal Cell, Melanoma, Mesothelioma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VET3-TGIDrug
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
AtezolizumabDrug
anti-pd-L1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Group A: VET3-TGI alone intratumoral | Experimental | 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. Receives: Drug: VET3-TGI |
| Group B: VET3-TGI intratumoral in combination with atezolizumab | Experimental | 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. Receives: Drug: VET3-TGI; Drug: Atezolizumab |
| Group C: VET3-TGI alone intravenous | Experimental | Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years. Receives: Drug: VET3-TGI |
| Group D: VET3-TGI intravenous in combination with atezolizumab | Experimental | 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. Receives: Drug: VET3-TGI; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 4 weeks
Secondary outcomes (8)
Efficacy assessment: overall response rate (ORR)
The number and proportion of patients with a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
Measured: 108 months
Efficacy assessment: Duration of response (DOR)
Median duration of response in patients with a CR or PR
Measured: 108 months
Efficacy assessment: disease control rate (DCR)
The number and proportion of patients with stable disease (SD), or a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
Measured: 108 months
Efficacy assessment: Time to tumor progression (TTP)
Median time until patient disease progression (PD)
Measured: 108 months
Efficacy assessment: Progression free survival (PFS)
Median duration of progression free survival of subjects
Measured: 108 months
Overall survival
median duration of survival across all subjects
Measured: 108 months
Immune changes in tissue and blood
number of subject tissue samples with immune cell infiltrates and heat map changes in the molecular signature of tissue samples
Measured: 6 weeks
VET3-TGI delivery and replication kinetics
Number of subject tissues with positive VET3-TGI gene signatures denoting delivery and complete replication of VET3-TGI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start16 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KaliVir Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444815
- Sponsor's protocol ID
- STEALTH-001
- Acronym
- STEALTH-001
- Status last verified
- Apr 2026
- First submitted
- 30 May 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data is aggregated.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06444815
- Acronym / sponsor ID
- STEALTH-001 / STEALTH-001
- Conditions
- Solid Tumor, Adult, Microsatellite Stable Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer, Kidney Cancer, Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KaliVir ImmunotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: VET3-TGI alone intratumoral | Experimental | Drug: VET3-TGIDose 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. |
| Group B: VET3-TGI intratumoral in combination with atezolizumab | Experimental | Drug: VET3-TGI, Drug: AtezolizumabVET3-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. |
| Group C: VET3-TGI alone intravenous | Experimental | Drug: VET3-TGIDose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years. |
| Group D: VET3-TGI intravenous in combination with atezolizumab | Experimental | Drug: VET3-TGI, Drug: AtezolizumabVET3-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VET3-TGIOncolytic vaccinia virus engineered with immunomodulatory transgenes | Drug | Group A: VET3-TGI alone intratumoral, Group B: VET3-TGI intratumoral in combination with atezolizumab, Group C: VET3-TGI alone intravenous, Group D: VET3-TGI intravenous in combination with atezolizumab |
| Atezolizumabanti-pd-L1 antibody | Drug | Group B: VET3-TGI intratumoral in combination with atezolizumab, Group D: VET3-TGI intravenous in combination with atezolizumab |
Primary outcome
Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab
Time frame: 108 months
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab
Time frame: 4 weeks
Number of dose limiting toxicities, as defined in the protocol, by dose group
Determine the recommended Phase 2 dose
Time frame: 4 weeks
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. Data is aggregated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Burke, MD contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VET3-TGI and Atezolizumab in people with Solid Tumor, Adult and Microsatellite Stable Colorectal Cancer, run by KaliVir Immunotherapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adina Pelusio (+13057722084, clinops@kalivir.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab (time frame: 108 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.