Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06832202

A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HER2-low Hormone Receptor Positive Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

About this study

experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male/female who are at least 18 years of age on the day of signing the informed consent.
  • With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
  • HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
  • 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

Exclusion criteria

  • Patients with other malignant tumors within 3 years before the randomization
  • Previous treatment with any HER2-target therapy
  • Uncontrolled or significant cardiovascular disease or infection
  • Lung-specific intercurrent clinically significant illnesses
  • Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
  • Patients with spinal cord compression or clinically active central nervous system metastases

Treatment and study plan

HLX22

Drug

HLX22 15mg/kg Q3W

Trastuzumab Deruxtecan

Drug

Trastuzumab Deruxtecan 5.4mg/kg Q3W

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to 5 years

    Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

  2. Objective response rate (ORR)

    Time frame: Up to 2 years

    Objective Response Rate (ORR) assessed by IRRC per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1

Secondary outcomes

  1. PFS

    Time frame: Up to 5 years

    PFS assessed by investigator per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

  2. ORR

    Time frame: Up to 2 years

    ORR assessed by investigator per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1

  3. Aderse events (AE)

    Time frame: Up to 5 years

    AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun Li

CONTACT

[email protected]

+86-15800864157

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study title

A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 18, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.