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Can a single eye injection shrink melanoma and save sight?

NCT ID NCT07747935

Disease control Sponsor: ReBio Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This early-phase trial is testing an investigational drug called RBP-01 (sotrastaurin), given as an injection into the eye, for people with primary uveal melanoma—a rare cancer of the eye. The study aims to see if the drug is safe and whether it can shrink the tumor enough to avoid eye removal (enucleation) or reduce the risk of vision loss from standard radiation therapy. Participants will receive the injection before their planned standard treatment, and researchers will monitor for side effects and measure tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an intravitreal injection of sotrastaurin (RBP-01)
What this could lead to
If it works, this could offer a way to shrink eye tumors before standard treatment, potentially saving the eye and preserving vision in people with uveal melanoma.
What could go wrong
This is an early-stage trial with a small number of participants, so the treatment may not prove effective or safe. Possible risks include side effects from the injection and the tumor not responding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uveal melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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