Clinical trial NCT03990077: Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Nsclc
Lead sponsor: Shanghai Kechow Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: Duration of the study, estimated to be approximately 24 months
measure: Maximum tolerated dose (MTD)
timeFrame: DLTs within the first cycle of therapy (up to 35 days)
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Duration of the study, estimated to be approximately 24 months
measure: Peak Plasma Concentration (Cmax)
timeFrame: Duration of the study, estimated to be approximately 24 months
measure: Area under the plasma concentration verus time curve(AUC)
timeFrame: Duration of the study, estimated to be approximately 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
Study officials:
affiliation: Shanghai Kechow Pharma.
name: Hongqi Tian, PhD
role: STUDY_DIRECTOR
References: