Safety and Tolerability of Intravenous Administration of ICVB-1042
Patients With Advanced Solid Tumors
About this trial
This is an interventional treatment trial for Patients With Advanced Solid Tumors focused on measuring Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated
Eligibility Criteria
Inclusion Criteria: Adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present Measurable disease according to RECIST v1.1 ECOG Performance Status 0 or 1 Life expectancy of at least 3 months Exclusion Criteria: Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy Major surgical procedures within 28 days prior to dosing Limited field irradiation for palliation within 14 days prior to dosing Anti-viral agents, vaccinations within 28 days prior to dosing Known central nervous system (CNS) metastases unless adequately treated and clinically stable without steroids for ≥14 days Leptomeningeal carcinomatosis Pulmonary lymphangitic spread of cancer History of clinically significant cardiovascular abnormalities Known active infection requiring systemic antibiotic therapy or systemic antifungal therapy Known active HIV, hepatitis B or C, or other active viral disease Known hematologic malignancies (requiring or not requiring active therapy). Requirement for immunosuppressive therapy (ie, prednisone equivalent of >10 mg/day) Women who are pregnant or lactating Oxygen saturation measured with Pulse oximeter <90% and/or on supplemental O2
Sites / Locations
- California Cancer AssociatesRecruiting
- Karmanos Cancer InstituteRecruiting
- NYU Langone Health, Perlmutter Cancer Center
- University of North Carolina Lineberger Comprehensive Cancer Center
- Carolina BioOncologyRecruiting
- University of Pennsylvania, Abramson Cancer Center
- Sarah Cannon Research Institute
- Next Oncology, DallasRecruiting
- Next Oncology, San AntonioRecruiting
- Next Oncology, VirginiaRecruiting
Arms of the Study
Arm 1
Experimental
ICVB-1042
Part A: Dose escalation Part B: Dose expansion