Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2024-09-16
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: VET3-TGI alone intratumoral
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.
VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Group B: VET3-TGI intratumoral in combination with pembrolizumab
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.
VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Pembrolizumab
anti-pd1 antibody
Group C: VET3-TGI alone intravenous
Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.
VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Group D: VET3-TGI intravenous in combination with pembrolizumab
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.
VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Pembrolizumab
anti-pd1 antibody
Interventions
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VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Pembrolizumab
anti-pd1 antibody
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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KaliVir Immunotherapeutics
INDUSTRY
Responsible Party
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Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
University of Miami
Miami, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
UPMC- Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Patient Contact
Role: primary
Other Identifiers
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STEALTH-001
Identifier Type: -
Identifier Source: org_study_id
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