Route90 FDA Pivotal Study

Multicenter Study Evaluating Efficacy & Safety of Eye90 microspheres® in HCC Using Personalized Dosimetry and Advanced Imaging Technology

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Route90 clinical study

Pivotal Study in HCC:

Radioembolization Oncology trial Utilizing Transarterial Eye90 (ROUTE 90) for the treatment of Hepatocellular Carcinoma (HCC)

 FDA IDE Approved

Route90 is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in patients living with unresectable Hepatocellular Carcinoma (HCC).

Endpoints

Effectiveness: Confirmed Overall Response Rate using local mRECIST, Duration of Response > 6 months

Safety: Incidence of Adverse Events and Serious Adverse Events 

Sites: 20

Subjects: 120 enrolled/treated 

Full FDA IDE Approval: May 2023

First Patient Enrolled: August 2023

First Patient Treated: October 2023

Principal Investigator: Andrew Kennedy, MD, FACRO

Study Director: Aravind Arepally, MD, CMO ABK Biomedical

ClinicalTrials.gov ID: NCT05953337

ABK Biomedical Advanced Imaging
To be eligible for study participation, each subject must meet the following criteria:
1. ≥ 18 years old at the time of informed consent.
2. Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LI-RADS) category 5 or confirmation of HCC via biopsy.
• Note: See Appendix 15.6 for information on LI-RADS classification.
• Note: If two separate perfused target volumes are required to treat all lesions, at least one lesion in a perfused target volume must be LI-RADS category 5 or be biopsy proven HCC.
3. No extra hepatic disease.
4. Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
5. Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume(s).
6. Intent to treat all lesions within a single session.
7. At least one target lesion must be Hypervascular on CBCT, CT, or MRI based on treating investigator’s assessment.
8. Evidence that > 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
9. Barcelona Clinic Liver Cancer (BCLC) stage A, B, or C.
10. Subjects who are not candidates for ablation, resection, or liver transplantation at time of enrollment.
11. Child-Pugh score of Class A.
12. Treatment-naïve subjects or subjects who have developed a new lesion following one of these prior locoregional treatments:
• Liver resection with negative pathologic margins, no microvascular invasion, and no recurrence at resection margins for at least 6 months posttreatment and no new lesions within 6 months of liver resection.
• Ablation of a single ≤ 3 cm lesion with no recurrence of the treated lesion for at least 6 months post-treatment.
13. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
14. For women: Negative serum pregnancy test at screening and baseline.
15. Is willing to give written informed consent after having been informed of the requirements and the restrictions of the study.
16. Is willing to comply with all requirements of the study, including exposure to repeat radiological imaging, following post treatment care instruction, completing study assessments, and attending all study visits.

 

First Time in Human Clinical Study

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

Route90 clinical study

The First in Human Clinical Study with Eye90 microspheres was initiated in Auckland, New Zealand in 2022.

Four of the first six patients treated showed a Complete Response by local mRECIST in a 3-month interim analysis. These data were presented by the Principal Investigator, Professor Andrew Holden, at the SIR Annual Meeting in March 2023.

Endpoints

Safety: Incidence of toxicity, Incidence of Treatment Emergent Serious Adverse Events 

Effectiveness: Overall Response Rate by RECIST 1.1, Overall Response Rate by mRECIST

ClinicalTrials.gov ID: NCT04926376

Closed to recruitment

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Corporate Offices

Halifax Office (Main Office)
155 Chain Lake Drive
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Halifax, NS B3S 1B3
Canada

T. 902.442.4009

 

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Ladera Ranch, CA, 92694
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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. Eye90 microspheres® is considered an investigational product and is NOT FDA-approved for use.

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