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

  • days left to enroll
  • participants needed
  • sponsor
    Shanghai Kechow Pharma, Inc.
Updated on 22 March 2022


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 Solid Tumor
Treatment Vemurafenib, HL-085
Clinical Study IdentifierNCT03781219
SponsorShanghai Kechow Pharma, Inc.
Last Modified on22 March 2022


Yes No Not Sure

Inclusion Criteria

BRAF V600 mutation in solid tumor
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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