Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
NCT06642545 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-02-17
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
Interventions
- 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
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-10
- Primary Completion
- 2026-10-01
- Completion
- 2027-10-01
Countries
- China
Study Locations
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