{"entity":{"id":"shr-a1921","kind":"drug","name":"SHR-A1921","aka":[],"tldr":"SHR-A1921 is an experimental drug that delivers chemotherapy to TROP2-bearing cells. Early solid-tumor findings are distinct from the later trials testing its comparative benefit.","summary":"The 2025 Cancer Cell publication reports a first-in-human phase 1 study, NCT05154604, in 391 patients with pretreated advanced or metastatic solid tumors. Overall ORR was 24.8% (95% CI 20.6 to 29.4), across several different tumor cohorts. This pooled rate is not a TNBC-specific estimate. Grade 3 or higher treatment-related events occurred in 132/391 patients (33.8%), including stomatitis in 57/391 (14.6%). The reported lack of a significant expression-efficacy correlation in this study does not validate universal expression independence or a companion diagnostic. Later registered phase 3 development is separate from this uncontrolled evidence.","status":"phase-3","asOf":"2026-10-06","links":[{"label":"First-in-human SHR-A1921, Cancer Cell 2025","url":"https://doi.org/10.1016/j.ccell.2025.09.012"},{"label":"Resolved PubMed record 41135519","url":"https://pubmed.ncbi.nlm.nih.gov/41135519/"},{"label":"ClinicalTrials.gov NCT05154604","url":"https://clinicaltrials.gov/study/NCT05154604"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["ovarian"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":[],"companies":["hengrui"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06394492","nct06474455","nct05765032"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"ADC","mechanism":"TROP2-targeted antibody-drug conjugate, identified in the primary first-in-human publication.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/shr-a1921/","neighbours":{"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"hengrui","kind":"company","name":"Jiangsu Hengrui Pharmaceuticals","route":"/companies/hengrui/"}],"trial":[{"id":"nct06474455","kind":"trial","name":"A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","route":"/trials/nct06474455/"},{"id":"nct06394492","kind":"trial","name":"SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer","route":"/trials/nct06394492/"},{"id":"nct05765032","kind":"trial","name":"Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors","route":"/trials/nct05765032/"}]}}