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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Each RBP-01 dose consists of a 5 µL intravitreal injection conjugating 250 µg of sotrastaurin.
Safety events
• The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study
Time frame: From first dose until 6 months
preliminary effectiveness
Tumor response as measured by protocol-defined primary Uveal Melanoma response criteria
Time frame: Up to 6 months
Eye salvage rate
Proportion of participants who remain free from enucleation (Cohort 1)
Time frame: Up to 6 months
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