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NCT07459738Not yet recruitingPhase 2

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (estimated)
First submitted
5 Mar 2026
Start date
1 Apr 2026
Primary completion date
30 Dec 2026
Lead sponsor
Shanghai Henlius Biotech
NCT number
NCT07459738

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 60
  • From 1 Apr 2026 to the primary completion date, 30 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/pneumonitis
  • Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.

Other illness

  • Patients with other malignant tumors within 3 years before the randomization
  • Lung-specific intercurrent clinically significant illnesses
  • Uncontrolled or significant cardiovascular disease or infection

Who the study is looking for

  • Male/female who are at least 18 years of age and and no more than 75 years old on the day of signing the informed consent.
  • With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
  • Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease.
  • Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
  • ECOG PS: 0-1.
  • Expected survival ≥ 6 months.
  • Had adequate organ function

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.