Clinical trial · Interventional
Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
A Phase 1b, Open-Label, Investigator-Led Study of Neoadjuvant RBP-01 In Patients With Primary Uveal Melanoma
NCT07747935CI-TRIAL-00120633Uveal Melanomanot yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant RBP-01 in patients with primary uveal melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RBP-01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RBP-01
- description
- All participants receive RBP-01 using the same dosing regimen
- interventionNames
- Drug: RBP-01
Primary outcomes (1)
- measure
- Safety events
- timeFrame
- From first dose until 6 months
- description
- • The incidence of AEs, TEAEs, SAEs and proportion of participants discontinuing from the study
Secondary outcomes (2)
- measure
- preliminary effectiveness
- timeFrame
- Up to 6 months
- description
- Tumor response as measured by protocol-defined primary Uveal Melanoma response criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.