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

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05092815
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
29.8
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
Actual Study Start Date :
Dec 6, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLX208

Participants receive HLX208 450mg bid po

Drug: HLX208
HLX208 450mg bid po
Other Names:
  • BRAF V600E inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [up to 1 year]

      Objective response rate(assessed by independent review committee (IRC) based on the PERCIST Version 1.0)

    Secondary Outcome Measures

    1. AEs [up to 1 year]

      Incidence and severity of adverse events

    2. ORR [up to 1 year]

      Objective response rate(assessed by the investigator based on the PERCIST v1.0)

    3. ORR [up to 1 year]

      Objective response rate(assessed by IRC and the investigator based on the RECIST v1.1)

    4. DCR [up to 1 year]

      Disease control rate (assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1 )

    5. TTR [up to 1 year]

      Time to response(assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1)

    6. PFS [from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 year]

      Progression-free survival (PFS) (assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1 )

    7. OS [from the date of first dose until the date of death from any cause，assessed up to 1 year]

      Overall survival

    8. Cmax [from the date of first dose to 85 days]

      Maximum Plasma Concentration

    9. Tmax [from the date of first dose to 85 days]

      Time of Maximum Plasma Concentration

    10. AUC [from the date of first dose to 85 days]

      Area Under the Curve

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Volunteer to participate in the clinical study;

    2. Aged ≥ 18 years;

    3. Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;

    4. At least one measurable lesion as per PERCIST v1.0;

    5. Expected survival time ≥ 3 months;

    6. ECOG score 0-2;

    Exclusion Criteria:

    1. Previous treatment with BRAF inhibitors or MEK inhibitors;

    2. 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;

    3. Severe active infections requiring systemic anti-infective therapy;

    4. Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Shanghai Henlius Biotech

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Henlius Biotech
    ClinicalTrials.gov Identifier:
    NCT05092815
    Other Study ID Numbers:
    • HLX208-LCH/ECD201
    First Posted:
    Oct 26, 2021
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Histiocytosis, Langerhans-Cell
    Histiocytosis
    Erdheim-Chester Disease

    Study Results

    No Results Posted as of Jan 4, 2022