Phase
Condition
Neoplasms
Treatment
Treatment with ICVB-1042 administered intravenously
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients with relapsed or refractory locally advanced or metastatic solidtumors who have progressed on or after at least one prior line of standard of caretherapy including immune checkpoint inhibitors and targeted therapies for knownmolecular alterations if present
Measurable disease according to RECIST v1.1
ECOG Performance Status 0 or 1
Life expectancy of at least 3 months
Exclusion
Exclusion Criteria:
Prior SOC or other treatment with a biologic (eg, mAb) within 28 days prior todosing 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 andclinically 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 antifungaltherapy
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
Study Design
Connect with a study center
California Cancer Associates
San Marcos, California 92069
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
NYU Langone Health, Perlmutter Cancer Center
New York, New York 10016
United StatesSite Not Available
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Carolina BioOncology
Huntersville, North Carolina 28078
United StatesSite Not Available
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Next Oncology, Dallas
Irving, Texas 75039
United StatesSite Not Available
Next Oncology, San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Next Oncology, Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
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