Clinical trial · Interventional
Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions
A Multicenter Phase 1B Pharmacodynamics Study of MRX34, MicroRNA miR-Rx34 Liposomal Injection, in Patients With Advanced Melanoma and Biopsy Accessible Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 5 immune related serious adverse events in Phase 1 study
Summary
Brief summary (as posted)
This study is designed to investigate the biomarkers, pharmacodynamics and pharmacokinetics of the liposomal micro-ribonucleic acid-34 (microRNA-34, miR-34). Melanoma patients with easily accessible lesions will undergo serial biopsies and serial blood samples will be collected.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| MRX34 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with MRX34
- description
- Liposomal Injection of MRX34 for 5 days followed by 16 days rest with premedication of dexamethasone daily.
- interventionNames
- Drug: MRX34
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Peak blood concentration and Area Under the Curve (AUC) of MRX34 after IV dosing and drug concentration in tissue biopsies
- timeFrame
- 3 months
Secondary outcomes (1)
- measure
- Frequency and severity of adverse events associated with MRX34 treatment
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * Advanced or metastatic cutaneous, acral or mucosal melanoma * Tumor lesions accessible to serial biopsies * ECOG ≤ 1 * ANC ≥, Plts ≥100,000 /mm3 Exclusion Criteria: * Serious active non-malignant disease * Central Nervous System metastasis
References
Publications (0)
Data not yet available