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

Sponsor
Shanghai Henlius Biotech
Study ID
NCT06832202
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER2-low Hormone Receptor Positive Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HLX22 — DRUG
    HLX22 15mg/kg Q3W
  • Trastuzumab Deruxtecan — DRUG
    Trastuzumab Deruxtecan 5.4mg/kg Q3W

Study Details

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).

Key Dates

Start date
Apr 16, 2025
Status verified
Jan 2025
Primary completion
Jun 1, 2027
Completion
Dec 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

Related Studies