# Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br

Source: https://onco.cc/trials/nct07487519/  
OnCo record `nct07487519` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT07487519: https://clinicaltrials.gov/study/NCT07487519

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Serplulimab](https://onco.cc/drugs/serplulimab/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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