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

NCT07747935 | Not Yet Recruiting Phase 1

• 1 other identifier: RBP01-UM-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neoadjuvant RBP-01 in patients with primary uveal melanoma.

Conditions

Uveal Melanoma

Keywords

UM

Outcome Measures

Primary Outcomes (1)

• Safety events

  • The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study

  From first dose until 6 months

Secondary Outcomes (2)

• preliminary effectiveness

  Up to 6 months

• Eye salvage rate

  Up to 6 months

Other Outcomes (1)

• Maximum Plasma Concentration of RBP-01

  at 1, 2, and 4 hours after the first dose of study intervention.

Study Arms (1)

RBP-01

EXPERIMENTAL

All participants receive RBP-01 using the same dosing regimen

Drug: RBP-01

Interventions

RBP-01 DRUG

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

RBP-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ReBio Pharma: lead

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Ido Didi Fabian, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lola Study Coordinator

CONTACT

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

Marie Santiago-Raber

CONTACT

marie.santiagoraber@rebio.fi

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 5, 2026

Record last verified: 2026-08