Trial Title:
A Study of VET3-TGI in Patients With Solid Tumors
NCT ID:
NCT06444815
Condition:
Solid Tumor, Adult
Microsatellite Stable Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Kidney Cancer
Renal Cell Carcinoma
Melanoma Stage IV
Merkel Cell Carcinoma of Skin
Mesothelioma
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Renal Cell
Mesothelioma
Squamous Cell Carcinoma of Head and Neck
Kidney Neoplasms
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VET3-TGI
Description:
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Arm group label:
Group A: VET3-TGI alone intratumoral
Arm group label:
Group B: VET3-TGI intratumoral in combination with pembrolizumab
Arm group label:
Group C: VET3-TGI alone intravenous
Arm group label:
Group D: VET3-TGI intravenous in combination with pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
anti-pd1 antibody
Arm group label:
Group B: VET3-TGI intratumoral in combination with pembrolizumab
Arm group label:
Group D: VET3-TGI intravenous in combination with pembrolizumab
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).
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 pembrolizumab. 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC/Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Xiomara Menendez, RN
Email:
Xiomara.Menendez@med.usc.edu
Facility:
Name:
Community Health Network
Address:
City:
Indianapolis
Zip:
46250
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Patient Contact
Phone:
317-621-2627
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Minal Barve, MD
Phone:
972-566-3000
Email:
referral@marycrowley.org
Investigator:
Last name:
Minal Barve, MD
Email:
Principal Investigator
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Patient contact
Email:
ClinOps@KaliVir.com
Start date:
September 16, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
KaliVir Immunotherapeutics
Agency class:
Industry
Source:
KaliVir Immunotherapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06444815
