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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
- ClinicalTrials.gov ID
- NCT07747935
- Acronym / sponsor ID
- Uveal Melanoma / RBP01-UM-001
- Conditions
- Uveal Melanoma
- Keywords
- UM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ReBio PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| RBP-01 | Experimental | Drug: RBP-01All participants receive RBP-01 using the same dosing regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBP-01Each RBP-01 dose consists of a 5 µL intravitreal injection conjugating 250 µg of sotrastaurin. | Drug | RBP-01 |
Primary outcome
Safety events
Time frame: From first dose until 6 months
• The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study
2 secondary outcomes
preliminary effectiveness
Time frame: Up to 6 months
Eye salvage rate
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Santiago-Raber contact
Ido Didi Fabian, Prof. principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RBP-01 in people with Uveal Melanoma, run by ReBio Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lola Study Coordinator (+972 3 530 5000, zilola.levayev@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety events (time frame: From first dose until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.