Actively Recruiting
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-01-10
160
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
CONDITIONS
Official Title
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent approved by ethics board
- Male or female aged 18 to 75 years
- ECOG performance status of 0 or 1
- Histopathologically diagnosed with locally advanced or metastatic triple negative breast cancer not suitable for radical therapy
- Have failed standard treatment or are new to systemic antitumor therapy in advanced setting
- Able to provide tumor tissue samples for testing
- Life expectancy of at least 12 weeks
- Have measurable disease according to RECIST version 1.1
- Have adequate organ functions
- Fertile subjects and their partners agree to use contraception during and for at least 6 months after treatment
- Willing to follow study procedures
You will not qualify if you...
- Existing treatment-related toxicity Grade 2 or higher and Grade 3 or higher immune-related adverse reactions
- Existing peripheral neuropathy Grade 2 or higher
- Hemoglobin A1C (HbA1c) of 8% or higher
- Eye conditions increasing risk of corneal damage
- History of interstitial lung disease or pneumonitis, severe or uncontrolled diseases, or central nervous system metastases
- Chemotherapy or radiotherapy within 21 days before first study drug dose (Cohort A)
- Immune checkpoint inhibitor or systemic immunosuppressive therapy within 14 days before first study drug dose (Cohorts B and C)
- Use of traditional Chinese medicine with anticancer indication within 14 days before first study drug dose
- Use of any investigational drug or device within 28 days before first study drug dose
- Prior treatment with nectin-4 targeted ADC with MMAE payload
- Use of P-glycoprotein inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days before first study drug dose
- Major surgery within 28 days before first study drug dose
- Live vaccines within 28 days before or during the study
- History of allogeneic hematopoietic stem cell or solid organ transplantation
- Known sensitivity to study drug ingredients
- History of drug abuse or mental illness
- History of pulmonary embolism or significant cardiac or cerebrovascular disease within 6 months before first study drug dose
- Active autoimmune disease requiring systemic treatment within 2 years before first study medication
- History of another cancer within 3 years before first study drug dose
- Not suitable for study treatment due to other medical conditions as per investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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