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)

11ms

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

11 months ago

Trial completion date • Trial primary completion date • Metastases

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M

bafisontamab (EMB-01)

1year

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

1 year ago

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)

over1year

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.

over 1 year ago

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)

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.

over 1 year ago

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)

over2years

EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers (clinicaltrials.gov)

P1/2, N=96, Recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd.

over 2 years ago

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)

over2years

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

over 2 years ago

Clinical • Enrollment change • Trial completion date • Trial primary completion date

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR T790M

bafisontamab (EMB-01)