Actively Recruiting
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Led by RemeGen Co., Ltd. · Updated on 2025-02-17
40
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Have stage III unresectable locally advanced or stage IV metastatic breast cancer
- Willing and able to provide tumor tissue suitable for HER2 and PD-L1 testing
- Confirmed HER2 low expression in invasive breast tumor tissue
- Negative hormone receptor status with less than 1% ER and PgR positive cells, or weakly positive with investigator approval
- Locally recurrent unresectable or untreated metastatic breast cancer, or completed curative treatment with required intervals from recurrence and prior taxane therapy
- ECOG performance status of 0 or 1
- At least one measurable lesion meeting RECIST v1.1 criteria
- Expected survival of at least 12 weeks
- Meet hematologic and organ function requirements within 7 days before first dose
- Female subjects of childbearing potential must have negative pregnancy test and agree to contraception and no breastfeeding
- Male subjects of childbearing potential must agree to abstain from sperm donation and use contraception
- Capable of understanding and complying with study requirements and follow-ups
You will not qualify if you...
- Prior anti-HER2 treatment including antibody-drug conjugates
- Previous immunotherapy with anti PD-(L)1 or similar drugs during advanced disease unless last dose was 12 months prior
- Brain or leptomeningeal metastases, except treated brain metastases without progression
- Use of investigational drugs or major surgery within 4 weeks before first dose
- Receipt or planned live vaccines within 4 weeks before or during the study
- History of allogeneic stem cell or organ transplantation
- Uncontrolled or significant heart or cerebrovascular disease including recent severe events
- Clinically uncontrollable fluid accumulation like large pleural effusion or ascites
- History or presence of severe lung disease including active tuberculosis
- History of neurological or psychiatric disorders such as epilepsy or dementia
- Unresolved toxicities from prior cancer treatments except certain mild conditions
- Persistent grade 2 or higher sensory or motor neuropathy
- Active infections requiring systemic treatment within 7 days before first dose, including positive HIV or active hepatitis B or C
- Active autoimmune diseases requiring systemic treatment within past 2 years except replacement therapies
- Other malignancies within 5 years except certain treated cancers
- Known allergies to study drugs or similar medications
- Serious diseases that may pose safety risks or affect study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cance Hosoltal Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiaohong Su
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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