A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.

Eligibility criteria

Qualifiers

Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.

Expected survival duration ≥ 3 months.

Metastatic tumor;

Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;

Disqualifiers

Uncontrolled or severe cardiovascular disease.

History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging.

Presence of pulmonary-specific, clinically significant comorbid conditions.

Presence of spinal cord compression, or clinically active central nervous system metastases.

Trial design

Treatments tested in this trial

  • SSGJ-612 (HER2-targeted antibody)
  • HER2-targeted ADC

Treatment groups

87 Participants
are divided into 2 treatment groups