^
    1m
    Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC (clinicaltrials.gov)
    P2, N=2, Terminated, Shanghai Henlius Biotech | N=49 --> 2 | Trial completion date: Apr 2026 --> Dec 2023 | Suspended --> Terminated | Trial primary completion date: Aug 2024 --> Dec 2023; Due to poor clinical trial accrual, the study was terminated.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • KRAS wild-type • RAS wild-type
    |
    Hetronifly (serplulimab) • HLX26
    9ms
    A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX26 Monoclonal Antibody Injection in Patients With Solid Tumor or Lymphoma (clinicaltrials.gov)
    P1, N=18, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed | N=11 --> 18
    Trial completion • Enrollment change • Metastases
    |
    HLX26
    9ms
    A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov)
    P2, N=132, Recruiting, Shanghai Henlius Biotech | N=60 --> 132
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • ROS1 rearrangement • LAG3 expression
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab) • HLX26
    9ms
    Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=9, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed
    Trial completion
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • HLX26
    1year
    Safety, preliminary efficacy, and pharmacokinetics of HLX26 plus serplulimab in advanced solid tumours: An open-label, dose-escalation phase I study (ESMO Asia 2023)
    Conclusions No new safety signals were observed for the different doses of HLX26 in combination with serplulimab. HLX26 plus serplulimab was safe and well tolerated in patients with advanced solid tumours who had failed or could not receive standard therapies.
    Clinical • P1 data • PK/PD data • Metastases
    |
    Hetronifly (serplulimab) • HLX26
    1year
    A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov)
    P2, N=60, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • ROS1 rearrangement • LAG3 expression
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Hetronifly (serplulimab) • HLX26
    1year
    Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Aug 2023
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • HLX26
    over1year
    Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC (clinicaltrials.gov)
    P2, N=49, Suspended, Shanghai Henlius Biotech | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • KRAS wild-type • RAS wild-type
    |
    Hetronifly (serplulimab) • HLX26
    over1year
    Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC (clinicaltrials.gov)
    P2, N=49, Recruiting, Shanghai Henlius Biotech | Trial completion date: Nov 2023 --> Apr 2026 | Trial primary completion date: Aug 2023 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • KRAS wild-type • RAS wild-type
    |
    Hetronifly (serplulimab) • HLX26
    over1year
    Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC (clinicaltrials.gov)
    P2, N=49, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting | Initiation date: Nov 2022 --> May 2023
    Enrollment open • Trial initiation date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • KRAS wild-type • RAS wild-type
    |
    Hetronifly (serplulimab) • HLX26
    over1year
    A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • LAG3 (Lymphocyte Activating 3)
    |
    PD-L1 expression • ROS1 rearrangement • LAG3 expression
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Hetronifly (serplulimab) • HLX26
    2years
    Evaluate the Efficacy, Safety and Tolerability of HLX26 and HLX10 in Patients With Metastatic Colorectal Carcinoma That Have Received 3 Prior Lines of Therapy (clinicaltrials.gov)
    P2, N=49, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial • Combination therapy • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • KRAS wild-type • RAS wild-type
    |
    Hetronifly (serplulimab) • HLX26
    2years
    Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=6, Recruiting, Shanghai Henlius Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • HLX26
    over2years
    Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Shanghai Henlius Biotech | Trial completion date: Jan 2023 --> Dec 2023 | Trial primary completion date: Jan 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • HLX26
    over2years
    Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 in Combination With HLX10 in Patients With Advanced/Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=9, Not yet recruiting, Shanghai Henlius Biotech
    New P1 trial • Combination therapy
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • HLX26