Safety and Tolerability of Intravenous Administration of ICVB-1042

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

Official Title
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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

Conditions
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Patients With Advanced Solid Tumors

Intervention / Treatment
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* Drug: Treatment with ICVB-1042 administered intravenously


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Escalating doses
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICVB-1042<br>Part A: Dose escalation Part B: Dose expansion | Drug: Treatment with ICVB-1042 administered intravenously<br>* Part A Dose Escalation to assess safety and tolerability of ascending dose levels, define the maximum tolerated dose (MTD), and expansion dose(s) Part B Dose Expansion to further assess safety and tolerability of 1 or more dose levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of intravenous ICVB-1042 | Assessment of treatment-emergent dose limiting toxicity | From dose administration through 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration profile of ICVB-1042 in plasma |  | Up to 48 hours after drug infusion | 
| Determine immunogenicity of ICVB-1042 | Assessment of anti-drug antibody titer | From dose administration through 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncolytic virus, First in human, Relapsed solid tumor, Refractory solid tumor, Tumor biopsy, Novel therapy, Metastatic, Previously treated