Safety and Tolerability of Intravenous Administration of ICVB-1042

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Status and phase

Terminated

Phase 1

Conditions

Patients With Advanced Solid Tumors

Treatments

Drug: Treatment with ICVB-1042 administered intravenously

Study type

Interventional

Funder types

Industry

Identifiers

1042-CLN01

Details and patient eligibility

About

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

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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