Safety and Tolerability of Intravenous Administration of ICVB-1042

Phase 1 First-in-Human Dose Escalation and Expansion Study to Assess Safety and Tolerability of Intravenous Administration of ICVB-1042 in Patients With Advanced Solid Tumors

Study to evaluate the safety and tolerability of intravenous ICVB-1042

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