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

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    45
  • sponsor
    Shanghai Kechow Pharma, Inc.
Updated on 22 March 2022

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.

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

Eligibility

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note