Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.

Official Title
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A Multi-Center, Open Label, Phase 1 Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 in Patients With Advanced Solid Tumors With Liver Involvement

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: ALN-VSP02


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy Patient has measurable tumor in the liver At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 Patient has adequate hematologic, liver, and renal function Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV) Patient has a life expectancy > 12 weeks Exclusion Criteria: Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin > 325 mg/day or other platelet inhibitory agents Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrythmia Patient has known active brain or leptomeningeal metastases Patient has clinically significant cerebrovascular disease Patient has a seizure disorder not controlled on medication Patient has a known or suspected viral, parasitic or fungal infection Patient previously experienced a severe reaction to a liposomal product Patient has a known hypersensitivity to lipid products

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALN-VSP02|IV infusion administered every two weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of intravenous ALN-VSP02 |  | up to 16 weeks (4 cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine PK of ALN-VSP02 |  | 8 weeks (two cycles) | 
| Assess preliminary evidence of antitumor/antiangiogenic activity |  | Up to 16 weeks (4 cycles) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement