Uveal MelanomaPhase 1/2Uveal MelanomaNCT07747935
Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
A Phase 1/2 study testing RBP-01 in people with Uveal Melanoma, run by ReBio Pharma.
Trial summary
Neoadjuvant RBP-01 in patients with primary uveal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- RBP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Apr 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Marie Santiago-Raber contact
About this study
Official title: A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
Neoadjuvant RBP-01 in patients with primary uveal melanoma.
Read the 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.
- Conditions
- Uveal Melanoma
- Being tested
- RBP-01
- Keywords
- UM
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBP-01Drug
Each RBP-01 dose consists of a 5 µL intravitreal injection conjugating 250 µg of sotrastaurin.
| Study group | Role | What they receive |
|---|---|---|
| RBP-01 | Experimental | All participants receive RBP-01 using the same dosing regimen Receives: Drug: RBP-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety events
- The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study
Measured: From first dose until 6 months
Secondary outcomes (2)
preliminary effectiveness
Tumor response as measured by protocol-defined primary Uveal Melanoma response criteria
Measured: Up to 6 months
Eye salvage rate
Proportion of participants who remain free from enucleation (Cohort 1)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReBio Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ido Didi Fabian, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747935
- Sponsor's protocol ID
- RBP01-UM-001
- Acronym
- Uveal Melanoma
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided