Study of HL-085 in NRAS Mutant Advanced Melanoma

Shanghai Kechow Pharma, Inc.42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Melanoma

Interventions

HL-085DRUG

HL-085 is one MEK inhibitor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Number of participants with adverse events

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

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

Maximum tolerated dose (MTD)

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)

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

Secondary Outcomes

Objective Response Rate (ORR) as measure of efficacy

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

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

Area under the plasma concentration versus time curve (AUC)

AUC of HL-085 following single and repeated dosing

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

Peak Plasma Concentration (Cmax)

Cmax of HL-085 following single and repeated dosing

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

Time to maximum observed plasma drug concentration (Tmax)

Tmax of HL-085 following single and repeated dosing

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

Half-life (T1/2)

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

Data from ClinicalTrials.gov

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