Enlituo (cetuximab biosimilar)

P1, N=86, Recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd

Cetuximab plus irinotecan, fluorouracil, and leucovorin (FOLFIRI) represents a first-line therapeutic standard for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients. Despite this established approach, cetuximab β (CMAB009), as a modified antibody of cetuximab, prospectively selected for dual RAS/BRAF wild-type patients, has not yet been validated in the Chinese mCRC patients through phase 3 trial...This study demonstrated that cetuximab β plus FOLFIRI provided significant clinical benefits as a first-line treatment for patients with RAS/BRAF wild-type mCRC. Compared to FOLFIRI alone, cetuximab β plus FOLFIRI therapy led to prolonged median PFS and OS while maintaining a manageable safety profile, offering a new treatment option for this patient population.

P3, N=520, Completed, Taizhou Mabtech Pharmaceutical Co.,Ltd | Active, not recruiting --> Completed

P3, N=520, Active, not recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Jun 2023 --> Jun 2024

P3, N=520, Active, not recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Jun 2022 --> Jun 2023

P3, N=520, Active, not recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Recruiting --> Active, not recruiting

P3, N=512, Recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Oct 2021 --> Mar 2022

P3, N=512, Recruiting, Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Apr 2021 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Oct 2021