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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781219
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Kechow Pharma, Inc.

Study Description
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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
Solid Tumor Drug: HL-085 Drug: Vemurafenib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : July 1, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vemurafenib

Arms and Interventions
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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 Name: ZELBORAF


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: up to 12 mouths ]
    Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781219


Contacts
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Contact: Jin Ma, Bachelor 86 13810268600 maj@kechowpharma.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Science Recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, M.D         
Beijing Oncology Hospital Recruiting
Beijing, Beijing, China
China, Henan
Henan Province Oncology Hospital Recruiting
Zhengzhou, Henan, China
China, Zhejiang
First Affiliated Hospital, Medicine School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Shanghai Kechow Pharma, Inc.
Investigators
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Study Director: Hongqi Tian, Ph.D Shanghai Kechow Pharma, Inc.
More Information
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Responsible Party: Shanghai Kechow Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03781219    
Other Study ID Numbers: HL-085-102
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Vemurafenib
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action