Drugs / BAFISONTAMAB
last change Jul 2026 re-read 9 days ago

BAFISONTAMAB

also known as EMB-01 · FIT-013a

Monoclonal antibody targets EGFR, MET via inhibition

Developed for
colorectal cancer · metastatic neoplasm · non-small cell lung carcinoma · carcinoid tumor
Investigated by
Shanghai EpimAb Biotherapeutics Co., Ltd. · Labcorp Corporation of America Holdings, Inc · Covance

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07649655 Jul 2026 → Mar 2028 expected colorectal cancer Shanghai EpimAb Biotherapeutics Co., Ltd. Not yet recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05498389 Jun 2023 → Jul 2024 non-small cell lung carcinoma Shanghai EpimAb Biotherapeutics Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT05176665 Oct 2021 → Dec 2025 overdue carcinoid tumor, metastatic neoplasm Shanghai EpimAb Biotherapeutics Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT03797391 Dec 2018 → Mar 2025 metastatic neoplasm, non-small cell lung carcinoma Shanghai EpimAb Biotherapeutics Co., Ltd. Unknown No outcome recorded
Phase 21 trial
Phase 2 NCT07314294 Dec 2025 → Dec 2027 expected colorectal cancer Shanghai EpimAb Biotherapeutics Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2022-06-08 Shanghai EpimAb Biotherapeutics Co., Ltd. Regulatory EpimAb Biotherapeutics Announces U.S. FDA Clearance of IND Application for Phase Ib/II Trial of EMB-01 in Combination with Tagrisso® for Non-Small Cell Lung Cancer epimab.com ↗
2020-06-22 Shanghai EpimAb Biotherapeutics Co., Ltd. Results EpimAb Biotherapeutics Presents Preclinical Data Characterizing EMB-01 at AACR Virtual Annual Meeting II epimab.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as BAFISONTAMAB ChEMBL registry synonym — accepted as the source's own label CHEMBL4594472 ↗
Known as EMB-01 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07314294 ↗
4

NCT07649655 ↗

NCT03797391 ↗

NCT05498389 ↗

NCT05176665 ↗

Known as FIT-013a ChEMBL registry synonym — accepted as the source's own label CHEMBL4594472 ↗
Action Inhibit “EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer.” NCT05498389 ↗
Modality Monoclonal antibody — CHEMBL4594472 ↗
Route Intravenous “receive intravenous infusions of EMB01” NCT03797391 ↗
Target EGFR “Epidermal growth factor receptor (EGFR)” NCT03797391 ↗
Target MET “c-Mesenchymal-Epithelial Transition (cMet)” NCT03797391 ↗