Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive HER-2 Negative Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX43 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HLX43 DOSE1
- description
- Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death,emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
- interventionNames
- Drug: HLX43
- type
- EXPERIMENTAL
- label
- HLX43 DOSE2
- description
- Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death,emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
- interventionNames
- Drug: HLX43
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer. 3. Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease. 4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only. 5. ECOG PS: 0-1. 6. Expected survival ≥ 6 months. 7. Had adequate organ function Exclusion Criteria: 1. Patients with other malignant tumors within 3 years before the randomization 2. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/pneumonitis 3. Lung-specific intercurrent clinically significant illnesses 4. Uncontrolled or significant cardiovascular disease or infection 5. Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.
References
Publications (0)
Data not yet available