mocertatug rezetecan (GSK5733584)

P3, N=450, Not yet recruiting, GlaxoSmithKline | Trial completion date: Jan 2030 --> Jul 2030 | Initiation date: Mar 2026 --> Jun 2026 | Trial primary completion date: Jan 2030 --> Jul 2030

P3, N=600, Not yet recruiting, GlaxoSmithKline | Initiation date: Mar 2026 --> Jun 2026

P3, N=468, Recruiting, Hansoh BioMedical R&D Company | Not yet recruiting --> Recruiting

P3, N=450, Not yet recruiting, GlaxoSmithKline

P3, N=600, Not yet recruiting, GlaxoSmithKline

P1/2, N=392, Recruiting, GlaxoSmithKline | Trial primary completion date: Sep 2027 --> Dec 2027

P1, N=385, Recruiting, GlaxoSmithKline | N=240 --> 385 | Trial primary completion date: Oct 2026 --> Feb 2027

P1, N=157, Recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

B7-H4-directed agents, particularly antibody-drug conjugates (ADCs) like puxitatug samrotecan (AZD8205), felmetatug vedotin (SGN-B7H4V), and GSK5733584, have demonstrated early clinical activity with promising response rates in triple-negative breast cancer (TNBC). Combination strategies, such as ADCs with anti-PD-1 or PARP inhibitor therapies, have also shown enhanced tumor regression in preclinical models and are the subject of several ongoing clinical trials. This review highlights the current landscape of B7-H4-targeted agents, their progress in clinical trials, and the potential for combination approaches to improve outcomes in B7-H4-expressing cancers.

P1/2, N=360, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting

P3, N=468, Not yet recruiting, Hansoh BioMedical R&D Company

P1/2, N=360, Not yet recruiting, GlaxoSmithKline | Phase classification: P1 --> P1/2 | Trial primary completion date: Jan 2027 --> Sep 2027