A Study of VET3-TGI in Patients With Solid Tumors
STEALTH-001
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
1 other identifier
interventional
60
1 country
7
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2024
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 6, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 10, 2025
April 1, 2025
3 years
May 30, 2024
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
108 months
Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with pembrolizumab
Number of dose limiting toxicities, as defined in the protocol, by dose group
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 pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation
4 weeks
Secondary Outcomes (8)
Efficacy assessment: overall response rate (ORR)
108 months
Efficacy assessment: Duration of response (DOR)
108 months
Efficacy assessment: disease control rate (DCR)
108 months
Efficacy assessment: Time to tumor progression (TTP)
108 months
Efficacy assessment: Progression free survival (PFS)
108 months
- +3 more secondary outcomes
Study Arms (4)
Group A: VET3-TGI alone intratumoral
EXPERIMENTALDose 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 pembrolizumab
EXPERIMENTALVET3-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 C: VET3-TGI alone intravenous
EXPERIMENTALDose 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 pembrolizumab
EXPERIMENTALVET3-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.
Interventions
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
anti-pd1 antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC Irvine Health
Orange, California, 92868, United States
University of Miami
Miami, Florida, 33136, United States
Community Health Network
Indianapolis, Indiana, 46250, United States
UPMC- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 6, 2024
Study Start
September 16, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
Data is aggregated.