Safety and Tolerability of Intravenous Administration of ICVB-1042

Stopped early · Phase 1

Conditions studied: Patients With Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT05904236

Run by

IconOVir Bio

People needed

17

Starts

2023-06-01

Expected to finish

2024-12-20

Last updated by the study team

2025-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Cancer Associates — San Marcos, California, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• NYU Langone Health, Perlmutter Cancer Center — New York, New York, United States
• University of North Carolina Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Carolina BioOncology — Huntersville, North Carolina, United States
• University of Pennsylvania, Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Next Oncology, Dallas — Irving, Texas, United States
• Next Oncology, San Antonio — San Antonio, Texas, United States
• Next Oncology, Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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