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A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Sponsor
Shanghai Kechow Pharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03781219
Collaborator
(none)
45
Enrollment
4
Locations
1
Arm
49
Anticipated Duration (Months)
11.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HL-085 plus Vemurafenib

HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID)

Drug: HL-085
HL-085 ( Capsule) is one MEK inhibitor.

Drug: Vemurafenib
Vemurafenib ( Tablet) is BRAF inhibitor,
Other Names:
  • ZELBORAF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Adverse Events [up to 12 mouths]

      Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. BRAF V600 mutation in solid tumor.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Science Beijing Beijing China 100021
    2 Beijing Oncology Hospital Beijing Beijing China
    3 Henan Province Oncology Hospital Zhengzhou Henan China
    4 First Affiliated Hospital, Medicine School of Zhejiang University Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Shanghai Kechow Pharma, Inc.

    Investigators

    • Study Director: Hongqi Tian, Ph.D, Shanghai Kechow Pharma, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Kechow Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT03781219
    Other Study ID Numbers:
    • HL-085-102
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Vemurafenib

    Study Results

    No Results Posted as of Jan 21, 2022