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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:
4d
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)
5d
New P2 trial • IO biomarker • Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
oxaliplatin • Hetronifly (serplulimab)
7d
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 overexpression
|
Herceptin (trastuzumab) • oxaliplatin • Hetronifly (serplulimab)
13d
SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases (clinicaltrials.gov)
P2, N=51, Recruiting, First Affiliated Hospital of Zhejiang University | N=102 --> 51
Enrollment change • Mismatch repair • pMMR
|
MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
capecitabine • oxaliplatin • Hetronifly (serplulimab)
15d
New P2 trial • IO biomarker
|
Fruzaqla (fruquintinib) • Hetronifly (serplulimab)
15d
New P2 trial • Checkpoint inhibition
|
HER-2 (Human epidermal growth factor receptor 2)
|
Hetronifly (serplulimab) • HLX43
27d
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
PD-L1 IHC 22C3 pharmDx
|
Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Hetronifly (serplulimab)
30d
New P2 trial
|
carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab) • TheraCIM (nimotuzumab)
1m
SCAR: Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, Zhejiang University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
|
capecitabine • oxaliplatin • Hetronifly (serplulimab) • celecoxib oral
1m
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=167, Recruiting, Shanghai Henlius Biotech | N=90 --> 167 | Trial completion date: Jul 2028 --> Jan 2029
Enrollment change • Trial completion date
|
Hetronifly (serplulimab) • pimurutamab (HLX07) • HLX43
1m
New P4 trial • Tumor mutational burden • pMMR
|
MSI (Microsatellite instability)
|
5-fluorouracil • oxaliplatin • Fruzaqla (fruquintinib) • leucovorin calcium • Hetronifly (serplulimab)
1m
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
oxaliplatin • Hetronifly (serplulimab) • Zadaxin (thymalfasin)