Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

• ClinicalTrials.gov Identifier: NCT04926376
• Recruitment Status: Recruiting
• First Posted: June 15, 2021
• Last Update Posted: January 31, 2023
• Sponsor: ABK Biomedical
• Information provided by (Responsible Party): ABK Biomedical

Tracking Information

• First Submitted Date: June 9, 2021
• First Posted Date: June 15, 2021
• Last Update Posted Date: January 31, 2023
• Actual Study Start Date: November 2, 2021
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2021)

• 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
• 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
• 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
• Overall Response Rate (ORR) by mRECIST [ Time Frame: 6 months ]
  ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
• Official Title: Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
• Brief Summary: 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, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to 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 study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Open Label

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Hepatocellular Carcinoma Non-resectable
• Metastatic Colorectal Cancer
• Liver Cancer

Intervention

Device: Eye90 Microspheres

Y90 glass microspheres

Study Arms

Experimental: EYE90 Microspheres Treament

Radioembolization with Eye90 Microspheres

Intervention: Device: Eye90 Microspheres

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 1, 2021): 10
• Original Enrollment: Not Provided
• Estimated Study Completion Date: September 2023
• Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

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 > 2 cm 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.
• No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
• 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).
• Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
• Estimated lung dose > 30 Gy as calculated using the lung shunt % and partition model.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABK Biomedical; +1.902.442.4009; safety@abkbiomedical.com

• Listed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT04926376
• Other Study ID Numbers: ABK-QA-PROT-37
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: ABK Biomedical
• Original Responsible Party: [Redacted]
• Current Study Sponsor: ABK Biomedical
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Study Director: Robert Abraham, MD, FSIR; ABK Biomedical

• PRS Account: ABK Biomedical
• Verification Date: January 2023