Trial to Evaluate the Safety and Feasibility of Belzupacap Sarotalocan (AU-011) for the Treatment of Conjunctival Melanoma, Melanocytic Lesions, or Conjunctival Squamous Cell Carcinoma in adult participants
A Phase 1 Open-Label Trial to Evaluate the Safety and Feasibility of Belzupacap Sarotalocan (AU-011) for the Treatment of Conjunctival Melanoma, Melanocytic Lesions, or Conjunctival Squamous Cell Carcinoma in adult participants.
Aura Biosciences, Inc.
36 participants
May 1, 2026
Interventional
Conditions
Summary
Brief description of the study purpose: This study aims to evaluate the safety and feasibility of belzupacap sarotalocan (bel-sar / AU-011) when used to treat conjunctival melanoma, melanocytic lesions, or conjunctival squamous cell carcinoma (SCC). Who is it for? You may be eligible for this study if you are a male or female, aged 18 years or older with a confirmed biopsy diagnosis of elevated or flat conjunctival melanoma, melanocytic lesions, or conjunctival squamous cell carcinoma, who hasve a tumour suitable for bel-sar injection and planned tumour excision. Study details Participants will receive one or multiple injections of bel-sar depending on their assigned cohort, with each injection followed by laser application. All participants who are eligible will receive treatment. Safety monitoring includes assessment of adverse events, vital signs, laboratory test (complete blood count and metabolic panel), and visual acuity. Blood samples will also be collected to measure serum concentrations of bel-sar. It is hoped that this research will determine provide information as to whether bel-sar, combined with laser activation, can be safely used as a new treatment approach for conjunctival tumours and ultimately contribute to improved options and patient outcomes.
Eligibility
Inclusion Criteria8
- Participants must:
- Be at least 18 years of age.
- Signed the informed consent form (ICF).
- A confirmed diagnosis of EM, FM or SCC based on results of biopsy at Screening.
- Have a new or recurrent tumour that currently meets eligibility criteria for the study tumour and planned tumour excision.
- Have at least 1 conjunctival tumour (i.e., the selected study tumour) deemed suitable for a bel-sar injection
- If born female and capable of becoming pregnant, have a negative pregnancy test at Screening and within 1 calendar day before bel-sar administration and must agree to use a highly effective method of contraception from the date of the screening pregnancy test through 90 days after the final dose of bel-sar.
- If born male and of reproductive potential with sexual partner(s) of childbearing potential, must agree to use a highly effective form of birth control from before administration of the first dose of bel-sar through 90 days after the final dose of bel-sar.
Exclusion Criteria12
- Participants must not:
- Have any ocular infection or an ocular disease other than the conjunctival tumour, that might progress during the trial and result in a change in vision, loss of vision, or confound trial assessments.
- Have a conjunctival tumour extending within the central 6-mm diameter of the cornea selected as the study tumour.
- Have had an ocular surgical procedure within 3 months of Screening.
- Use of heparin or low molecular weight heparins within 1 week of bel-sar treatment or use of pentosan polysulfate within 1 year of Screening.
- Must not have any additional malignancy that requires active treatment.
- Have a known immune-deficiency state/myelodysplastic disorder, bone marrow failure, human immunodeficiency virus (HIV) infection, history of solid organ transplant or bone marrow allograft, or recent pregnancy.
- Have an active bacterial, fungal, or viral infection.
- Have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the Investigator may increase the risk associated with trial participation, or interfere with evaluation of bel-sar or interpretation of participant safety or trial results.
- Have known hepatitis B or C infection.
- Have used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Screening or concurrently enrolled in another trial.
- Have known contraindications or sensitivities to phthalocyanine-based dye, the capsid component in bel-sar, or to prior ocular treatment with laser.
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Interventions
The trial has 3 open-label arms based on the type of tumour present. Tumour arms will be assessed together. - Elevated Conjunctival Melanoma (EM) - Flat Conjunctival Melanoma (FM) - Conjunctival Squamous cell carcinoma (SCC) The allocation to each treatment group will be determined by the type of cancer the participant has. There are 4 Cohorts in the study: Cohort 1: Participants in the EM, SCC and FM arms will receive a single 100ug injection of study drug bel-sar followed by laser application approximately 4 to 6 hours post-injection (wavelength 689 nm, intensity-at-target 600 mW/cm2, and fluence-at-target 50 J/cm2). Cohort 1a: Participants in the EM, SCC and FM arms will receive a single 40ug injection of study drug bel-sar followed by laser application approximately 4 to 6 hours post-injection (wavelength 689 nm, intensity-at-target 600 mW/cm2, and fluence-at-target 50 J/cm2). Cohort 2: Participants in the EM, SCC and FM arms will receive two 100ug injections of study drug bel-sar, each injection followed by laser application approximately 4 to 6 hours post-injection (wavelength 689 nm, intensity-at-target 600 mW/cm2, and fluence-at-target 50 J/cm2). The second treatment will be adminstered 7 days after the first treatment. Cohort 1b: Participants in the EM, SCC and FM arms will receive two 40ug injections of study drug bel-sar followed by laser application approximately 4 to 6 hours post-injection (wavelength 689 nm, intensity-at-target 600 mW/cm2, and fluence-at-target 50 J/cm2). The second treatment will be adminstered 7 days after the first treatment. At the completetion of each Cohort, there will be an Safety Review Board (SRB) review and there will be independent dose modifications as appropriate. Treatment (bel-sar and laser application) will be administered by an ophthalmologist in the research clinic and adherence will monitored by site staff. Cohort allocation is determined by the type of cancer the patient has, and the timing of participation and the study cohort currently active. Participants will undergo scheduled standard of care (SOC) tumour excision after the Cohort treatment is completed.
Locations(1)
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ACTRN12626000465358