Clinical trial · Interventional
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was terminated for scientific reasons.
Summary
Brief summary (as posted)
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AEB071 | Drug | Sotrastaurin Acetate | ALIAS |
| MEK162 | Drug | Binimetinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- AEB071 and MEK162 combined
- interventionNames
- Drug: AEB071
- Drug: MEK162
- type
- EXPERIMENTAL
- label
- Arm B
- description
- MEK162 alone
- interventionNames
- Drug: MEK162
Primary outcomes (2)
- measure
- Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
- timeFrame
- Cycle 1 (up to 28 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Male and female patients aged 18 years or older * A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease * Consent to providing 3 tumor biopsy samples throughout the course of the study * Presence of measurable disease * A WHO performance status of less than or equal to 1 Exclusion Criteria: * Presence of CNS lesions (stable lesions may be acceptable) * Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years * Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2 * History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO * Impaired cardiac function or clinically significant cardiac disease * Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162 * Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment * Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception * Males who are unwilling or unable to use a condom during sexual intercourse * Prior exposure to a MEK or PKC inhibitor Other inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available