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. 2022 Aug 12;24(4):339. doi: 10.3892/ol.2022.13459

Table I.

Completed/ongoing clinical trials of RC48 in HER2 breast cancer treatment.

A, Completed trials

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%.

B, Ongoing studies

Study phase Registration no. Arms and interventions Condition Subjects Outcomes/status

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.