^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Eisai, Fosun Pharma, Shanghai Henlius Biotech, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    6d
    Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment (clinicaltrials.gov)
    P2, N=66, Recruiting, Guangdong Association of Clinical Trials | N=36 --> 66
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    carboplatin • etoposide IV • Hetronifly (serplulimab)
    13d
    SPUR: Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC (clinicaltrials.gov)
    P2, N=61, Active, not recruiting, Sichuan University | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2026
    Enrollment closed • Trial completion date
    |
    cisplatin • carboplatin • etoposide IV • Hetronifly (serplulimab)
    14d
    Durable response to FOLFOX plus serplulimab in AFP-producing gastric adenocarcinoma with liver metastases: a case report and literature review. (PubMed, Front Immunol)
    AFP kinetics provided a rapid and reproducible on-treatment biomarker that complemented imaging. Given the paucity of prospective data in AFP-high gastric cancer, this report is hypothesis-generating and supports further evaluation of chemo-immunotherapy in larger studies.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    AFP (Alpha-fetoprotein) • GPC3 (Glypican 3) • CDX2 (Caudal Type Homeobox 2) • SALL4 (Spalt Like Transcription Factor 4)
    |
    5-fluorouracil • leucovorin calcium • Hetronifly (serplulimab)
    14d
    Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer (clinicaltrials.gov)
    P1, N=100, Recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2027 --> Dec 2028
    Enrollment open • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    Hetronifly (serplulimab) • alveltamig (ZG006)
    19d
    Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction (clinicaltrials.gov)
    P2, N=116, Recruiting, Xijing Hospital | Trial primary completion date: Mar 2026 --> May 2026
    Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • oxaliplatin • Hetronifly (serplulimab) • Teysuno (gimeracil/oteracil/tegafur)
    19d
    A Randomized, Three-Cohort Study to Evaluate the Efficacy and Safety of Different Time-of-Day Administration of Serplulimab Combined with Chemotherapy as Neoadjuvant Therapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (TD-NICE-Timing) (ChiCTR2600121582)
    P=N/A, N=135, Tangdu Hospital, Air Force Medical University; Tangdu Hospital, Air Force Medical University,
    New trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    19d
    A randomized exploratory three-cohort study evaluating the impact of time-of-day administration on the efficacy and safety of serplulimab plus chemotherapy as neoadjuvant treatment for stage II– IIIb non-small-cell lung cancer (TD-LUNG-Timing) (ChiCTR2600121500)
    P2/3, N=120, Tangdu Hospital, Air Force Medical University; Tangdu Hospital, Air Force Medical University,
    New P2/3 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Hetronifly (serplulimab)
    20d
    A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Chongqing University Cancer Hospital
    New P2 trial
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab) • Oncorine (recombinant human adenovirus type 5)
    22d
    Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients (clinicaltrials.gov)
    P2/3, N=156, Recruiting, Sun Yat-sen University | Trial completion date: Dec 2028 --> Dec 2029
    Trial completion date • pMMR
    |
    BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
    |
    BRAF wild-type
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Hetronifly (serplulimab)
    22d
    SCREEN: Serplulimab, Chidamide, and Rituximab Followed by Sequential R-CHOP for Newly Diagnosed Elderly MYC/BCL2 Double-Expressor DLBCL (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Sun Yat-sen University
    New P2 trial
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • Epidaza (chidamide) • Hetronifly (serplulimab)
    28d
    Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Multi-center Randomized Control Phase II Trial (clinicaltrials.gov)
    P2, N=165, Not yet recruiting, Fudan University
    New P2 trial • pMMR
    |
    MSI (Microsatellite instability)
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab)
    1m
    Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment (clinicaltrials.gov)
    P2, N=36, Recruiting, Guangdong Association of Clinical Trials | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    carboplatin • etoposide IV • Hetronifly (serplulimab)