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Datalai (cetuximab biosimilar)
i
Other names: cetuximab N01, A140, KL 140, KL-140, A 140, A-140, KL140
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Company:
Sichuan Kelun Pharma
Drug class:
EGFR antagonist
Related drugs:
29d
KL140-I-01-CTP: Safety and Pharmacokinetics of Recombinant Anti-EGFr Antibody in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
P1, N=18, Completed, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Unknown status --> Completed
Trial completion
|
Erbitux (cetuximab) • Datalai (cetuximab biosimilar)
29d
FALCO: Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases (clinicaltrials.gov)
P2, N=40, Recruiting, Zhejiang University
New P2 trial
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
KRAS mutation • KRAS G12C • BRAF mutation • NRAS mutation • BRAF wild-type • KRAS G12 • NRAS wild-type • NRAS G12
|
Erbitux (cetuximab) • Dupert (fulzerasib) • Datalai (cetuximab biosimilar)
29d
KL140-III-01: Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial (clinicaltrials.gov)
P3, N=52, Terminated, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | N=570 --> 52 | Recruiting --> Terminated; Due to adjustments in our R&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.
Enrollment change • Trial termination
|
BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus)
|
BRAF V600E • BRAF V600 • BRAF wild-type • RAS wild-type • BRAF V600 wild-type
|
oxaliplatin • leucovorin calcium • Datalai (cetuximab biosimilar)
11ms
A140 plus mFOLFOX6 compared with cetuximab plus mFOLFOX6 for first-line RAS wild-type metastatic colorectal cancer: A randomized clinical trial. (PubMed, Eur J Cancer)
A140 plus mFOLFOX6 is equivalent to cetuximab plus mFOLFOX6 for RASwt mCRC, with no appreciable differences in safety profiles. A140 plus mFOLFOX6 may provide a new treatment option for patients with RASwt mCRC.
Clinical • Journal
|
RAS (Rat Sarcoma Virus)
|
RAS wild-type
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • Datalai (cetuximab biosimilar)
almost2years
KL140-Ⅲ-02-CTP: Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC (clinicaltrials.gov)
P3, N=688, Completed, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Recruiting --> Completed | Trial completion date: Apr 2023 --> Jan 2024
Trial completion • Trial completion date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • Datalai (cetuximab biosimilar)
5years
Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC (clinicaltrials.gov)
P3, N=686, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Clinical • New P3 trial
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • BRAF V600
|
Erbitux (cetuximab) • oxaliplatin • Datalai (cetuximab biosimilar)
7years
Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial (clinicaltrials.gov)
P3, N=570, Recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Clinical • New P3 trial
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600
|
oxaliplatin • Datalai (cetuximab biosimilar)
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