RecruitingPhase 1NCT06444815

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

Sponsor

KaliVir Immunotherapeutics

Enrollment

60 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Solid Tumor, Adult Renal Cell Carcinoma Kidney Cancer Mesothelioma Melanoma Stage IV Microsatellite Stable Colorectal Cancer Merkel Cell Carcinoma of Skin

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria6

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).