{"entity":{"id":"nct07487519","kind":"trial","name":"Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br","aka":[],"tldr":"A phase 2 trial of serplulimab in triple-negative breast cancer, run by Shanghai Henlius Biotech, not yet recruiting.","summary":"Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. is a phase 2, randomised interventional study registered as NCT07487519 by Shanghai Henlius Biotech, with a registry enrolment figure of 180 participants, started 2026-04-25 and due to reach its primary completion in 2027-05-15. Interventions recorded: HLX43 DOSE 1 IN ≥2L TNBC; HLX43 DOSE 2 IN ≥2L TNBC; HLX43 DOSE 1 + HLX10; HLX43 DOSE1 IN 1L TNBC; HLX43 DOSE 2 IN 1L TNBC; HLX43 DOSE2 + HLX10. Conditions listed: Breast Cancer (Triple Negative Breast Cancer (TNBC)). Triple-negative eligibility wording from the registry: \"Histopathologically confirmed TNBC: ER \\< 1%, PR \\< 1%, HER2 IHC 0/1+/2+ with no FISH amplification\". Sites: China. No results are recorded here; the registry entry is the source.","status":"planned","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07487519","url":"https://clinicaltrials.gov/study/NCT07487519"}],"tags":["ctgov-ingest","tnbc-deep-dive"],"related":[],"cancers":["tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["serplulimab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07487519","phase":"2","setting":"A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).","sponsor":"Shanghai Henlius Biotech","enrolled":180,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07487519/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"serplulimab","kind":"drug","name":"Serplulimab","route":"/drugs/serplulimab/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}]}}