Actively Recruiting
Study of 9MW2821 Alone or With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer A Phase 2 Clinical Trial Evaluating Treatment Safety and Effectiveness
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
Researchers are evaluating the effectiveness and safety of 9MW2821 alone or combined with a PD-1 inhibitor in adults with locally advanced or metastatic Triple-Negative Breast Cancer. This Phase 2, open-label, multicenter study focuses on patients who have either failed standard treatments or are new to systemic therapy for advanced disease. The goal is to better understand how these therapies work in this challenging breast cancer type. Participants will receive intravenous infusions of 9MW2821 according to the study protocol. Some will receive 9MW2821 alone, while others will receive it combined with a PD-1 inhibitor, also given by intravenous infusion. Treatment schedules and dosing will be managed as per protocol to assess both monotherapy and combination therapy effects. During the study, participants will be monitored closely with evaluations of their tumor response over up to 24 months. Researchers will assess measurable disease using defined criteria and check organ function and overall health regularly. Safety will be tracked throughout, including monitoring for immune-related side effects and other adverse events. Participants must agree to contraception use if fertile and follow all study procedures during their involvement.
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
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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
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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