- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03990077
Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Beijing, China, 100021
- Cancer Hospital Chinese Academy of Medical Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- KRAS mutation NSCLC.
- One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
- 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:
- Hypersensitivity to study drug ingredients or their analogues.
- Prior therapy with MEK-inhibitor.
- Receiving any other anti-cancer therapy at the same time .
- Active central nervous system (CNS) lesion.
- Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
- ECG QTcB≥480msec in screening, or history of congenital long QT syndrome;
- 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 increase the risk of study and influence the result.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: dose escalation of HL-085 plus Docetaxel
HL-085 will be administered as BID with specified dose. And Docetaxel will be taken as the instruction in the label ( 75mg/m2,IV). f no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects. |
HL-085 ( Capsule) is one MEK inhibitor.
Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events (AEs)
Time Frame: Duration of the study, estimated to be approximately 24 months
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Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
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Duration of the study, estimated to be approximately 24 months
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Maximum tolerated dose (MTD)
Time Frame: DLTs within the first cycle of therapy (up to 35 days)
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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)
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DLTs within the first cycle of therapy (up to 35 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: Duration of the study, estimated to be approximately 24 months
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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.
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Duration of the study, estimated to be approximately 24 months
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Peak Plasma Concentration (Cmax)
Time Frame: Duration of the study, estimated to be approximately 24 months
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Cmax is the maximum plasma concentration of HL-085 or metabolite(s).
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Duration of the study, estimated to be approximately 24 months
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Area under the plasma concentration verus time curve(AUC)
Time Frame: Duration of the study, estimated to be approximately 24 months
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AUC of HL-085 or metabolites(s) after repeated dosing
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Duration of the study, estimated to be approximately 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hongqi Tian, PhD, Shanghai Kechow Pharma.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- HL-085-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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