^
    8ms
    Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects (clinicaltrials.gov)
    P1, N=20, Completed, Shanghai Henlius Biotech | Not yet recruiting --> Completed | N=52 --> 20 | Trial primary completion date: Sep 2023 --> Dec 2023
    Trial completion • Enrollment change • Trial primary completion date
    |
    itraconazole • RX208 • rifampicin
    10ms
    Mass Balance Study of [14C]HLX208 in China Healthy Subjects (clinicaltrials.gov)
    P1, N=6, Completed, Shanghai Henlius Biotech | Not yet recruiting --> Completed
    Trial completion
    |
    RX208
    1year
    HLX208, a novel BRAF V600E inhibitor, in adult patients with Langerhans cell histiocytosis and/or Erdheim-Chester disease harbouring BRAF V600E mutation (ESMO Asia 2023)
    No treatment-emergent AEs leading to death occurred. Conclusions HLX208 showed promising efficacy in adult patients with LCH and/or ECD harbouring BRAF V600E mutation, with a manageable safety profile.
    Clinical
    |
    BRAF V600E
    |
    RX208
    over1year
    Study on Food Influence and Drug-drug Interaction of HLX208 Tablets in Chinese Healthy Subjects (clinicaltrials.gov)
    P1, N=52, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial
    |
    itraconazole • RX208 • rifampicin
    over1year
    A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation (clinicaltrials.gov)
    P1/2, N=49, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • BRAF V600E • BRAF V600
    |
    Hetronifly (serplulimab) • RX208
    almost2years
    A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation (clinicaltrials.gov)
    P1/2, N=49, Not yet recruiting, Shanghai Henlius Biotech
    New P1/2 trial • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • BRAF V600E • BRAF V600
    |
    Hetronifly (serplulimab) • RX208
    over2years
    A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation (clinicaltrials.gov)
    P2, N=30, Recruiting, Shanghai Henlius Biotech | Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: Apr 2023 --> Aug 2023
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    RX208
    almost3years
    A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation (clinicaltrials.gov)
    P2, N=20, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    RX208
    3years
    A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation (clinicaltrials.gov)
    P2, N=30, Recruiting, Shanghai Henlius Biotech
    Clinical • New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    RX208
    3years
    A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Shanghai Henlius Biotech
    Clinical • New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600
    |
    RX208