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RECRUITINGPhase 1INTERVENTIONAL

A Study of VET3-TGI in Patients With Solid Tumors

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Key Who May Qualify: - 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 - You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 - Demonstrate your organs (liver, kidneys, etc.) are working well enough based on blood tests - Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions Additional Inclusion criteria exist Key Who Should NOT Join This Trial: - previous cancer treatment that works throughout the body (like chemotherapy) 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. - cancer that has spread to the brain 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 weakened immune system (e.g. transplant recipient, etc). Additional Exclusion criteria exist Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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

Treatments Being Tested

DRUG

VET3-TGI

Oncolytic vaccinia virus engineered with immunomodulatory transgenes

DRUG

Pembrolizumab

anti-pd1 antibody

Locations (7)

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