A Study of VET3-TGI in Patients With Solid Tumors

Launched by KALIVIR IMMUNOTHERAPEUTICS · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VET3-TGI, which is an oncolytic immunotherapy designed to help patients with advanced solid tumors. This trial aims to find out the safest and most effective way to give VET3-TGI, either by injecting it directly into the tumor or through an intravenous line (into the vein). The study will also test how well VET3-TGI works when combined with another treatment called pembrolizumab, which is already used for some cancers.

To participate, patients must have advanced cancer that cannot be surgically removed and have already tried or cannot tolerate standard treatments like chemotherapy or immunotherapy. Eligible participants should be adults aged 65 to 74, have measurable tumors, and be in good overall health. If someone joins the trial, they can expect close monitoring and follow-up care throughout the study. It's an opportunity to access a new treatment while contributing to important research that may help others in the future.

Gender

ALL

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