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Completed

NCT Number: NCT03973151

Study of HL-085 in NRAS Mutant Advanced Melanoma

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 .

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HL-085

Drug

HL-085 is one MEK inhibitor.

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Duration of the study, estimated to be approximately 24 months.

    Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period

  2. Maximum tolerated dose (MTD)

    Time frame: DLTs within the first cycle of therapy (up to 35 days)

    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)

Secondary outcomes

  1. Objective Response Rate (ORR) as measure of efficacy

    Time frame: Duration of the study, estimated to be approximately 24 months.

    Efficacy estimated as the Objective Response Rate (ORR) , which is the sum of Partial Response (PR) and Complete Response (CR) as determined by RECIST 1.1

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: Duration of the study, estimated to be approximately 24 months

    AUC of HL-085 following single and repeated dosing

  3. Peak Plasma Concentration (Cmax)

    Time frame: Duration of the study, estimated to be approximately 24 months

    Cmax of HL-085 following single and repeated dosing

  4. Time to maximum observed plasma drug concentration (Tmax)

    Time frame: Duration of the study, estimated to be approximately 24 months.

    Tmax of HL-085 following single and repeated dosing

  5. Half-life (T1/2)

    Time frame: Duration of the study, estimated to be approximately 24 months.

    T1/2 of HL-085 following single and repeated dosing

Sponsors and collaborators

Lead sponsor

Shanghai Kechow Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2019
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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