A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.

Timeline

Start

2023-04-06

Primary completion

2024-12-30

Completion

2026-12-30

Outcome

Met primary endpoint

release “Becotatug Vedotin组经BICR评估的ORR为30.2%，化疗组ORR为11.5%，数值近三倍提升” lepubiopharma.com ↗

release “显著降低疾病进展或死亡风险37%（5.82个月vs. 2.83个月；HR=0.63，P=0.0146）。” lepubiopharma.com ↗

Publications

• Han F, Lv X, Zhou YJ, He Q, Guo Y, Xiang YQ, Shu XL, Pan SM, Qu SH, Zhang P, Jiang Y, Xu MJ, Lei KJ, Qu S, Wang XH, Jin YS, Zhao B, Dai R, Wang FH, Xu RH. Becotatug vedotin, MRG003, in previously treated recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm, phase IIa trial. Med. 2026 Apr 10;7(4):101029. doi: 10.1016/j.medj.2026.101029. Epub 2026 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Becotatug Vedotin	Other / unclassified	2 mg/kg	Intravenous
Subject	Becotatug Vedotin	Other / unclassified	2.3 mg/kg	Intravenous
Comparator	Capecitabine	Small molecule	1000 mg/m2	Oral
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous

Indications