Clinical trial · Interventional
Study of HL-085 in NRAS Mutant Advanced Melanoma
A Phase I/II, Single Arm, Dose Escalation and Cohort Expansion Study to Evaluate Safety, Preliminary Efficacy of HL-085 in Patients With NRAS Mutant Advanced Melanoma
NCT03973151CI-TRIAL-00066776completedPhase 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)
This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced 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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HL-085 | Drug | Tunlametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HL-085
- description
- HL-085 will be administered as BID with specified dose.
- interventionNames
- Drug: HL-085
Primary outcomes (2)
- measure
- Number of participants with adverse events
- timeFrame
- Duration of the study, estimated to be approximately 24 months.
- description
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- DLTs within the first cycle of therapy (up to 35 days)
- description
- The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010). 2. Subjects must have NRAS mutation in melanoma. 3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment. 4. ECOG performance status of 0-1. 5. Life expectancy ≥ 3 months. 6. Ability to take the medicine orally. 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior therapy with a MEK-inhibitor 2. Patients with known hypersensitivity to study drug ingredients or their analogues. 3. Active central nervous system (CNS) lesion. 4. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome. 5. Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment. 6. Uncontrolled concomitant diseases or infectious diseases. 7. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.). 8. History of HIV,HCV,HBV infection. 9. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded. 10. Serum HCG test is positive. 11. Other conditions that influence the results and increase the risk of study.
References
Publications (1)
- DERIVEDWang X, Luo Z, Chen J, Chen Y, Ji D, Fan L, Chen L, Zhao Q, Hu P, Sun P, Jia Z, Guo J, Si L. First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. BMC Med. 2023 Jan 4;21(1):2. doi: 10.1186/s12916-022-02669-7. PMID 36600247