First Time in Human Study

Y90 radioembolization with Eye90 microspheres

Eye90 Microspheres™ Clinical Development

Our lead development product, Eye90 microspheres™, is being studied for the first time in humans.

Conventional Y90 radioembolization has been used to treat over 100,000 patients with liver tumors since 2002. Eye90 microspheres™ has the potential to significantly improve the clinical success of Y90 radioembolization, leveraging state-of-the-art tumor imaging science and advanced microsphere engineering technologies.

This study is assessing Eye90 microspheres™ for the treatment of patients with unresectable hepatocellular cancer (HCC) or metastatic colorectal cancer (mCRC) in collaboration with Auckland Hospital Research Unit, New Zealand.

Study Design and Conduct

Study Description

The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres™ in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors that have an abnormally large number of blood vessels attached to them. Eye90 microspheres™ is internal radiation brachytherapy for the treatment of liver tumors that uses microspheres, tiny glass beads smaller in diameter than human hair, to provide radiation.

The microspheres contain Yttrium-90 (Y90) as the radiation source, which is used to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the doctor to confirm the microspheres have been delivered precisely to the tumor; this may help to improve the outcome of treatment.

Study Design

Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

Patients in this single-center, open-label study will receive a single Eye90 microspheres™ radioembolization treatment with follow-up visits for one year to assess safety, effectiveness, and quality of life measures.

The study will be conducted at Auckland Hospital, New Zealand

Eligibility Criteria

Inclusion Criteria;

Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).

Must have at least one lesion >2cm within the target perfused volume.

At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.

Total linear length of all lesions must be ≤ 9 cm.

Must have preservation of >700cc of normal liver parenchyma outside of treated volume.

Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.

Life expectancy of ≥ 6 months.

≥18 years old.

Exclusion Criteria

Hemoglobin ≤ 85 mg/L.

Platelet count < 50,000/microliter or prothrombin (PT) activity > 50% normal

INR > 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).

ALT > 2.5x upper limit

AST > 2.5x upper limit

For HCC subjects, Bilirubin ≥ 2 mg/dL.

For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.

eGFR ≤ 60 mL/min/1.73 m2.

Portal vein thrombosis (PVT)

Estimated lung dose > 30 Gy as calculated using the lung shunt % and partition

Outcome Measures

1 – Incidence of toxicity [ Time Frame: 6 months ]

Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

2 – Incidence of TESAEs [ Time Frame: 6 months ]

Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

3 – Overall Response Rate (ORR) by RECIST 1.1 [ Time Frame: 6 months ]

ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline

4 – Overall Response Rate (ORR) by mRECIST [ Time Frame: 6 months ]

ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

Further Information

For further information on the Eye90 microspheres™ First Time in Human Study please visit the ClinicalTrials.gov website

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ABK Biomedical Inc. provides and continues to provide accurate information on its website. However, ABK Biomedical Inc. assumes no responsibility for the accuracy and/or completeness, express or implied, as to the information contained or omitted and/or the products described. Furthermore, ABK Biomedical Inc. may change the products mentioned, and their stage in development, at any time without notice. ABK Biomedical Inc. is a clinical-stage company engaged in the research and development of new medical devices. ABK Biomedical Inc. products are considered investigational products and are NOT FDA approved for use. Y90 radioembolization

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