Risvutatug Rezetecan — Investigational Agent
Antibody-Drug Conjugate · Phase 3 · Hansoh Pharma (licensed to GSK)
Mechanism of Action
Risvutatug rezetecan (HS-20093 / GSK5764227) is a humanized anti-B7-H3 (CD276) antibody-drug conjugate carrying a topoisomerase I inhibitor payload via a cleavable tetrapeptide linker. B7-H3 (CD276) is a type I transmembrane protein of the B7 immune regulatory family that is broadly overexpressed across multiple solid tumors — including osteosarcoma, SCLC, NSCLC, urothelial carcinoma, and others — while having relatively limited normal-tissue expression. Upon binding B7-H3 on the tumor cell surface, risvutatug rezetecan is internalized; intracellular linker cleavage releases the active…
Investigational Indications
- Relapsed or refractory osteosarcoma after ≥2 prior lines of systemic therapy — FDA Breakthrough Therapy Designation; pivotal phase 3 ARTEMIS-011 met primary IRC-assessed PFS endpoint (July 2026)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Relapsed/refractory small cell lung cancer
- Non-small cell lung cancer (B7-H3-expressing)
- B7-H3-expressing solid tumors (broad development program)