Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC

Nsclc Clinical Trial

Official title:

A Phase I , Single Arm, Dose Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03990077
• Other study ID #: HL-085-103
• Status: Terminated
• Phase: Phase 1
• Start date: May 21, 2020
• Est. completion date: July 20, 2021

Study information

• Verified date: December 2020
• Source: Shanghai Kechow Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I, open label, dose escalation study to evaluate tolerability, safety , pharmacokinetics and efficacy in patients with KRAS mutant NSCLC by using HL-085 and Docetaxel.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. KRAS mutation NSCLC.

2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.

3. Chemotherapy, immunotherapy or radiotherapy = 4 weeks prior to starting the study treatment.

4. Surgery (except for tumor biopsy) or severe trauma = 14 days prior to starting the study treatment.

5. ECOG performance status of 0-1.

6. Life expectancy = 3 months.

7. Ability to take the medicine orally.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hypersensitivity to study drug ingredients or their analogues.

2. Prior therapy with MEK-inhibitor.

3. Receiving any other anti-cancer therapy at the same time .

4. Active central nervous system (CNS) lesion.

5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.

6. ECG QTcB=480msec in screening, or history of congenital long QT syndrome;

7. Uncontrolled concomitant diseases or infectious diseases.

8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).

9. History of HIV,HCV,HBV infection.

10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.

11. Serum HCG test is positive.

12. Other conditions that increase the risk of study and influence the result.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Nsclc

Intervention

Drug:
• HL-085
HL-085 ( Capsule) is one MEK inhibitor.
• Docetaxel
Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing

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 Adverse Events (AEs)	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.	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 more than 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	Overall response rate (ORR)	ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed per response evaluation criteria in solid tumors (RECIST) v1.1.	Duration of the study, estimated to be approximately 24 months
Secondary	Peak Plasma Concentration (Cmax)	Cmax is the maximum plasma concentration of HL-085 or metabolite(s).	Duration of the study, estimated to be approximately 24 months
Secondary	Area under the plasma concentration verus time curve(AUC)	AUC of HL-085 or metabolites(s) after repeated dosing	Duration of the study, estimated to be approximately 24 months