NCT06105008

Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer

An Randomized, Open-label, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive, HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.

Detailed description

Eligible patients will be those patients who have had disease progression on at least 1 previous line of endocrine therapies given for the treatment of metastatic disease or relapsed within 12 months of the end of adjuvant endocrine therapy or during adjuvant endocrine therapy, patients treated with CDK4/6 inhibitors require ≥50%. All patients must have historically confirmed HR positive, HER2-low (defined as IHC2+/ISH- and IHC 1+) expression, as determined by central laboratory testing results, advanced breast cancer. IHC 1+ account for no more than 60% The study aims to evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC. This study aims to see if RC48-ADC with JS001 allows patients to live longer without the cancer getting worse, compared to patients receiving RC48-ADC. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	2.0 mg/kg intravenous (lV) infusion every 2 weeks
DRUG	Toripalimab	3.0 mg/kg intravenous (lV) infusion every 2 weeks

Timeline

• Start date: 2024-12-20
• Primary completion: 2025-12-20
• Completion: 2026-04-10
• First posted: 2023-10-27
• Last updated: 2024-08-23

Locations

3 sites across 1 country: China