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

> **NCT07487519** · PHASE2 · NOT_YET_RECRUITING · sponsor: **Shanghai Henlius Biotech** · enrollment: 180 (estimated)

## Conditions studied

- Breast Cancer (Triple Negative Breast Cancer (TNBC))

## Interventions

- **DRUG:** HLX43 DOSE 1 IN ≥2L TNBC
- **DRUG:** HLX43 DOSE 2 IN ≥2L TNBC
- **DRUG:** HLX43 DOSE 1 + HLX10
- **DRUG:** HLX43 DOSE1 IN 1L TNBC
- **DRUG:** HLX43 DOSE 2 IN 1L TNBC
- **DRUG:** HLX43 DOSE2 + HLX10

## Key facts

- **NCT ID:** NCT07487519
- **Lead sponsor:** Shanghai Henlius Biotech
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-04-25
- **Primary completion:** 2027-05-15
- **Final completion:** 2028-05-22
- **Target enrollment:** 180 (ESTIMATED)
- **Last updated:** 2026-03-23


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07487519, "Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT07487519. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*