Study of HL-085 in NRAS Mutant Advanced Melanoma

Melanoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973151
• Other study ID #: HL-085-101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2017
• Est. completion date: January 18, 2021

Study information

• Verified date: May 2023
• Source: Shanghai Kechow Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• HL-085
HL-085 is one MEK inhibitor.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Kechow Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period	Duration of the study, estimated to be approximately 24 months.
Primary	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)	DLTs within the first cycle of therapy (up to 35 days)
Secondary	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	Duration of the study, estimated to be approximately 24 months.
Secondary	Area under the plasma concentration versus time curve (AUC)	AUC of HL-085 following single and repeated dosing	Duration of the study, estimated to be approximately 24 months
Secondary	Peak Plasma Concentration (Cmax)	Cmax of HL-085 following single and repeated dosing	Duration of the study, estimated to be approximately 24 months
Secondary	Time to maximum observed plasma drug concentration (Tmax)	Tmax of HL-085 following single and repeated dosing	Duration of the study, estimated to be approximately 24 months.
Secondary	Half-life (T1/2)	T1/2 of HL-085 following single and repeated dosing	Duration of the study, estimated to be approximately 24 months.