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

ConditionUveal Melanoma

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorReBio Pharma

About this trial

Neoadjuvant RBP-01 in patients with primary uveal melanoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: RBP-01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety events

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

Time frame

From first dose until 6 months

Secondary outcomes

preliminary effectiveness

Tumor response as measured by protocol-defined primary Uveal Melanoma response criteria

Time frame

Up to 6 months

Eye salvage rate

Proportion of participants who remain free from enucleation (Cohort 1)

Time frame

Up to 6 months

Other outcomes

Maximum Plasma Concentration of RBP-01

Maximum Plasma Concentration of sotrastaurin

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ReBio Pharma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: