Trial | NCT03973151  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    HL-085

  • Study Participants

    42
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 .
Study Started
Sep 01
2017
Primary Completion
Jan 18
2021
Study Completion
Jan 18
2021
Last Update
May 31
2023

Drug HL-085

HL-085 is one MEK inhibitor.

HL-085 Experimental

HL-085 will be administered as BID with specified dose.

Criteria 

Inclusion Criteria:

Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).
Subjects must have NRAS mutation in melanoma.
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.
ECOG performance status of 0-1.
Life expectancy ≥ 3 months.
Ability to take the medicine orally.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Prior therapy with a MEK-inhibitor
Patients with known hypersensitivity to study drug ingredients or their analogues.
Active central nervous system (CNS) lesion.
ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment.
Uncontrolled concomitant diseases or infectious diseases.
Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
History of HIV,HCV,HBV infection.
Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
Serum HCG test is positive.
Other conditions that influence the results and increase the risk of study.
No Results Posted