Treatment of advanced solid tumors with VET3-TGI immunotherapy
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
PHASE1 · KaliVir Immunotherapeutics · NCT06444815
This study is testing a new cancer treatment called VET3-TGI to see if it can safely target and kill cancer cells in patients with advanced solid tumors, either by injecting it directly into the tumors or giving it through an IV.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KaliVir Immunotherapeutics (industry) |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy, atezolizumab |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT06444815 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates VET3-TGI, an oncolytic immunotherapy designed to target and kill cancer cells while sparing healthy cells. The study is a Phase 1 dose escalation trial that will assess the safety and efficacy of VET3-TGI administered either through direct injection into tumors or intravenously, both alone and in combination with pembrolizumab. The trial will involve multiple groups to determine the highest tolerated doses of VET3-TGI and will expand to include additional patients for efficacy evaluation once these doses are established.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced, unresectable, or metastatic solid tumors who have failed or are intolerant to standard treatments.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is novel in its specific application, similar oncolytic immunotherapies have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 6 other locations
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
- UC Irvine Health — Orange, California, United States (RECRUITING)
- University of Miami — Miami, Florida, United States (RECRUITING)
- Community Health Network — Indianapolis, Indiana, United States (RECRUITING)
- UPMC- Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Mary Crowley Cancer Research — Dallas, Texas, United States (RECRUITING)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Adina Pelusio
- Email: clinops@kalivir.com
- Phone: +13057722084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: 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