The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    25
  • sponsor
    Shanghai Henlius Biotech
Updated on 22 March 2022

Summary

The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).

Details
Condition Langerhans Cell Histiocytosis, Erdheim-Chester Disease, LCH, ECD
Treatment HLX208
Clinical Study IdentifierNCT05092815
SponsorShanghai Henlius Biotech
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Volunteer to participate in the clinical study
Aged ≥ 18 years
Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation
At least one measurable lesion as per PERCIST v1.0
Expected survival time ≥ 3 months
ECOG score 0-2

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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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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