**Combined CTIMP and device trial** Study of bel-sar (AU-011) treatment vs sham in subjects with IL/CM

  • Research type

    Research Study

  • Full title

    A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

  • IRAS ID

    336003

  • Contact name

    Catherine Carter

  • Contact email

    Catherine.Carter@Parexel.com

  • Sponsor organisation

    Aura Biosciences, Inc.

  • Clinicaltrials.gov Identifier

    NCT06007690

  • Clinicaltrials.gov Identifier

    EU CT Number, 2023-504655-27-00

  • Duration of Study in the UK

    2 years, 9 months, 18 days

  • Research summary

    Researchers are looking for a potentially better way for treating 2 types of eye cancer, known as indeterminate lesions or choroidal melanoma, while lowering the risk of having to have surgery.

    Aura Biosciences, Inc. (the sponsor of the study) is currently developing an investigational treatment called belzupacap sarotalocan (bel-sar), which is injected into the eye using an investigational device called a microinjector (a small syringe with a needle attached). After the injection, an investigational laser system is then used to shine light on the tumour in the eye to activate bel-sar. The reason for this is because bel-sar is a light activated liquid which aims to target and destroy tumour cells in the eye, without affecting the healthy cells.

    The aim of the study is to see how safe and effective bel-sar is when given to people with the following types of eye cancer: indeterminate lesions or choroidal melanoma.

    This study will include approximately 100 participants across several countries globally.

    Patients will be randomly (a bit like throwing a dice) assigned to 1 of 3 treatment groups:
    1. Higher dose of bel-sar treatment
    2. Lower dose of bel-sar treatment
    3. Sham treatment – this is the control group; the treatment will not contain any active medication. The sham procedure will be the same as for the study medication and laser light application except that no study medication will be injected in the eye (only firm pressure to the eyeball will be applied with a needleless syringe) and no laser light will be applied during the sham laser procedure.

    Participants will be in this study for up to about 104 weeks (about 2 years).

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    24/NW/0052

  • Date of REC Opinion

    28 Mar 2024

  • REC opinion

    Further Information Favourable Opinion