Treatment of advanced solid tumors with VET3-TGI immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Adina Pelusio
• Email: clinops@kalivir.com
• Phone: +13057722084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.