Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RBP-01.
- Who it may be relevant to
- Registry conditions: Uveal Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
Overview
Neoadjuvant RBP-01 in patients with primary uveal melanoma.
Detailed description
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.
Interventions
- Drug RBP-01
Each RBP-01 dose consists of a 5 µL intravitreal injection conjugating 250 µg of sotrastaurin.
Primary outcome measures
- Safety events [Time frame: From first dose until 6 months]
Secondary outcome measures (2)
- preliminary effectiveness [Time frame: Up to 6 months]
- Eye salvage rate [Time frame: Up to 6 months]
Eligibility criteria
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.
9\. Female participants who are pregnant or lactating. 10. Participant is unable to follow protocol requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07747935 · RBP01-UM-001