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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 | Clinical Trials | Clareo Health

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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

NCT07459738•Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

April 1, 2026

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2027

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Hormone Receptor Positive HER-2 Negative Breast Cancer

Interventions

HLX43

DRUG

Contacts

Liman Zhang

CONTACT

18501255848 liman_zhang@henlius.com

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285

Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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