NCT05331326

A Study of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

A Multicenter, Single Arm Phase II Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of HER2-expression Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single-arm phase II clinical trial to evaluate the efficacy and safety of RC48 in metastatic human epidermal growth factor receptor 2 (HER2) expressing breast cancer with abnormal activation of PAM pathway.

Detailed description

A multicenter, single-arm study was conducted in 32 patients with HER2-positive breast cancer and 32 HER2-low expression patients to explore the efficacy and safety of RC48 in metastatic human epidermal growth factor receptor 2 (HER2) expressing breast cancer with abnormal activation of PAM pathway.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	RC48-ADC	RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-01
• Completion: 2024-08-01
• First posted: 2022-04-15
• Last updated: 2022-04-15

Locations

3 sites across 1 country: China