The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    40
  • sponsor
    Shanghai Henlius Biotech
Updated on 14 May 2022

Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation

Details
Condition Brain Tumor, Primary
Treatment HLX208
Clinical Study IdentifierNCT05092802
SponsorShanghai Henlius Biotech
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age>=18Y
Good Organ Function
Expected survival time ≥ 3 months
Refractory primary brain tumors with BRAF mutation that have been diagnosed
Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
ECOG score 0-1

Exclusion Criteria

Previous treatment with BRAF inhibitors or MEK inhibitors
A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
Severe active infections requiring systemic anti-infective therapy
Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period
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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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