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

A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07747935

Acronym

Uveal Melanoma

Enrollment

Registered

2026-08-05

Start date

2026-10-01

Completion date

2028-04-01

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma

Keywords

Brief summary

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

DRUGRBP-01

Each RBP-01 dose consists of a 5 µL intravitreal injection conjugating 250 µg of sotrastaurin.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

This is an open-label, non-randomized study with two treatment cohorts. All participants receive RBP-01 using the same dosing regimen. Cohort 1 includes participants whose uveal melanoma requires enucleation, and Cohort 2 includes participants requiring plaque brachytherapy who are at high risk of vision loss.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male and female participants aged ≥18 years. 2. Participants with choroidal and ciliary body \[P13.1\] tumours. 3. Participants with primary localized UM requiring enucleation (Cohort 1) or plaque brachytherapy at high risk of vision loss (Cohort 2), as per investigator assessment. 4. Participants with ECOG performance status 0-1. 5. Tumour thickness \> 4 mm. 6. Females of child bearing potential must have a negative urine pregnancy test result at screening.

Exclusion criteria

1. Participant has received previous treatment with a PKC inhibitor at any time. 2. Participant has received a prior diagnosis of metastatic disease. 3. Presence of a tumour originating from the iris. 4. Presence of intractable untreatable raised intraocular pressure. 5. Presence of ring melanoma. 6. Presence of severe glaucoma or uveitis. 7. 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety events	From first dose until 6 months	• The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study

Secondary

Measure	Time frame	Description
preliminary effectiveness	Up to 6 months	Tumor response as measured by protocol-defined primary Uveal Melanoma response criteria
Eye salvage rate	Up to 6 months	Proportion of participants who remain free from enucleation (Cohort 1)

Contacts

CONTACTLola Study Coordinator

zilola.levayev@sheba.health.gov.il+972 3 530 5000

CONTACTMarie Santiago-Raber

marie.santiagoraber@rebio.fi

PRINCIPAL_INVESTIGATORIdo Didi Fabian, Prof.

Sheba Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026