Table I.
A, Completed trials | |||||
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Study phase | Registration no. | Arms and interventions | Condition | Subjects | Outcomes/status |
I | NCT02881138 | RC48-ADC | HER2-positive metastatic breast cancer | 23 | ORR: 72.7% in 11 trastumab pretreated pts; SD: 28.6% in 14 pts at dose ≥1.5 mg/kg; PR: 57.1%. |
I | NCT03052634 | RC48-ADC | HER2-positive metastatic breast cancer | 30 | ORR: 36.7%; SD: 60%; CBR: 46.7%. |
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B, Ongoing studies | |||||
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Study phase | Registration no. | Arms and interventions | Condition | Subjects | Outcomes/status |
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II/III | NCT03500380 | RC48-ADC vs. Lapatinib + Capecitabine | HER2-positive metastatic breast cancer with or without liver metastases | 301 | Recruiting |
II | NCT03052634 | RC48-ADC | Advanced breast cancer with HER2 positive or HER2 low expression | 112 | Active, not recruiting |
III | NCT04400695 | RC48-ADC vs. Paclitaxel or Docetaxel or Vinorelbine Tartrate or Capecitabine | HER2 low breast cancer with recurrence/metastasis | 366 | Recruiting |
II | NCT05134519 | RC48-ADC | HER2-positive breast cancer | 20 | Not yet recruiting |
ORR, overall response rate; SD, stable disease; PR, partial response; CBR, clinical benefit rate; pts, patients; HER2, human epidermal growth factor receptor 2; ADC, antibody-drug conjugates; RC48, Disitamab Vedotin.