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bafisontamab (EMB-01)
i
Other names: EMB-01, FIT-013a, EMB01, FIT013a, EMB 01, FIT 013a
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Company:
EpimAb Biotherap
Drug class:
EGFR inhibitor, c-MET inhibitor
Related drugs:
3ms
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov)
P1/2, N=152, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR (Fibroblast Growth Factor Receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
|
bafisontamab (EMB-01)
1year
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov)
P1/2, N=152, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd. | N=96 --> 152
Enrollment change • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR (Fibroblast Growth Factor Receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
|
KRAS mutation • BRAF mutation • NRAS mutation • MET amplification • EGFR amplification • EGFR overexpression
|
bafisontamab (EMB-01)
over1year
A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=186, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd. | Trial completion date: Mar 2023 --> Jan 2026 | Trial primary completion date: Mar 2023 --> Mar 2025
Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
bafisontamab (EMB-01)
over1year
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (clinicaltrials.gov)
P1/2, N=115, Not yet recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd. | Initiation date: Oct 2022 --> Jun 2023
Trial initiation date • Combination therapy • Metastases
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation • ERBB3 mutation
|
Tagrisso (osimertinib) • bafisontamab (EMB-01)
2years
Integrative genomic analysis of drug resistance in MET exon 14 skipping lung cancer using patient-derived xenograft models. (PubMed, Front Oncol)
PDX mice were then treated with MET inhibitors (crizotinib and tepotinib) and EGFR-MET bispecific antibodies (EMB-01 and amivantamab) to evaluate their drug response in vivo. We also established and characterized a pair of METex14 NSCLC PDXs, including the first crizotinib resistant METex14 PDX. And dual inhibition of MET and EGFR might be a therapeutic strategy for EGFR-driven drug resistance METex14 lung cancer.
Preclinical • Journal
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • EGFR amplification • EGFR overexpression • MET exon 14 mutation • MET D1228H
|
Xalkori (crizotinib) • Rybrevant (amivantamab-vmjw) • Tepmetko (tepotinib) • bafisontamab (EMB-01)
over2years
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer (clinicaltrials.gov)
P1/2, N=115, Not yet recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd.
New P1/2 trial • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation • ERBB3 mutation
|
Tagrisso (osimertinib) • bafisontamab (EMB-01)
almost3years
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov)
P1/2, N=96, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd.
Clinical • New P1/2 trial
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET amplification • EGFR expression • EGFR overexpression • MET overexpression
|
bafisontamab (EMB-01)
3years
A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=186, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd. | N=137 --> 186 | Trial completion date: Mar 2024 --> Mar 2023 | Trial primary completion date: Mar 2024 --> Mar 2023
Clinical • Enrollment change • Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR T790M
|
bafisontamab (EMB-01)
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