Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma

Phase 1b open-label study to evaluate the safety, tolerability, and preliminary efficacy of the localized Protein Kinase C (PKC) inhibitor RBP-01 in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will receive neoadjuvant treatment for up to 6 months, followed by definitive local therapy.

Inclusion criteria

• Male and female participants aged ≥18 years.
• Participants with choroidal and ciliary body [P13.1] tumours.
• Participants with primary localized UM requiring enucleation (Cohort 1) or plaque brachytherapy at high risk of vision loss (Cohort 2), as per investigator assessment.
• Participants with ECOG performance status 0-1.
• Tumour thickness > 4 mm.
• Females of child bearing potential must have a negative urine pregnancy test result at screening.

Exclusion criteria

• Participant has received previous treatment with a PKC inhibitor at any time.
• Participant has received a prior diagnosis of metastatic disease.
• Presence of a tumour originating from the iris.
• Presence of intractable untreatable raised intraocular pressure.
• Presence of ring melanoma.
• Presence of severe glaucoma or uveitis.
• Participant is under active treatment for any other macular condition.

• Female participants who are pregnant or lactating. 10. Participant is unable to follow protocol requirements.