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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:
2d
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)
2d
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)
8d
New P2 trial • pMMR
|
MSI (Microsatellite instability)
|
capecitabine • oxaliplatin • Hetronifly (serplulimab)
19d
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)
20d
New P2 trial • IO biomarker • Circulating tumor DNA
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
oxaliplatin • Hetronifly (serplulimab)
21d
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 overexpression
|
Herceptin (trastuzumab) • oxaliplatin • Hetronifly (serplulimab)
28d
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)
30d
New P2 trial • IO biomarker
|
Fruzaqla (fruquintinib) • Hetronifly (serplulimab)
30d
New P2 trial • Checkpoint inhibition
|
HER-2 (Human epidermal growth factor receptor 2)
|
Hetronifly (serplulimab) • HLX43
1m
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)
1m
New P2 trial
|
carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab) • TheraCIM (nimotuzumab)
2ms
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