NCT06642545

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin	Disitamab Vedotin 2.0mg/kg,intravenous infusion, every 2 weeks
DRUG	RC148	20mg/kg, intravenous infusion, once every 2 weeks
DRUG	Albumin-bound Paclitaxone	125 mg/m2,intravenous infusion, D1-8, every 3 weeks
DRUG	Toripalimab	240mg,intravenous infusion, once every 3 weeks

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-10-15
• Last updated: 2025-02-17

Locations

1 site across 1 country: China