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

NCT ID: NCT03990077

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Nsclc

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

If 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HL-085

Intervention Type DRUG

HL-085 ( Capsule) is one MEK inhibitor.

Docetaxel

Intervention Type DRUG

Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.

Interventions

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HL-085

HL-085 ( Capsule) is one MEK inhibitor.

Intervention Type DRUG

Docetaxel

Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Kechow Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongqi Tian, PhD

Role: STUDY_DIRECTOR

Shanghai Kechow Pharma.

Locations

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Cancer Hospital Chinese Academy of Medical Science

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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HL-085-103

Identifier Type: -

Identifier Source: org_study_id