A Phase 2 interventional study of HLX22 and Trastuzumab Deruxtecan in HER2-low Hormone Receptor Positive Breast Cancer, sponsored by Shanghai Henlius Biotech. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Shanghai Henlius Biotech · Phase 2, Interventional, and Treatment
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).
experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shanghai Henlius Biotech is the lead sponsor of 128 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W
Drug: HLX22 · Drug: Trastuzumab Deruxtecan
HLX22 15mg/kg Q3W
Trastuzumab Deruxtecan 5.4mg/kg Q3W
Progression-Free Survival (PFS)
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.
Time frame: Up to 5 years
Objective response rate (ORR)
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
Time frame: Up to 2 years
PFS
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.
Time frame: Up to 5 years
ORR
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
Time frame: Up to 2 years
Aderse events (AE)
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.
Time frame: Up to 5 years
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Shanghai Henlius Biotech