Actively Recruiting
A Phase II Clinical Study of Efficacy and Safety of 9MW2821 Monotherapy or Combined With 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the drug 9MW2821 alone or combined with a PD-1 inhibitor in people with locally advanced or metastatic Triple-Negative Breast Cancer who are not suitable for radical therapy. This Phase 2, open-label study aims to understand how well these treatments work and how safe they are for this condition. Participants receive intravenous infusions of 9MW2821 alone or in combination with a PD-1 inhibitor according to the study protocol. The study includes different treatment groups: one with 9MW2821 alone, one with 9MW2821 plus a PD-1 inhibitor, and one where participants may receive either 9MW2821 alone or combined with a PD-1 inhibitor. The treatments are given as part of a randomized design without masking. Throughout the study, participants will have their response to treatment measured up to 24 months, including detailed assessments of tumor response, duration, and control of the disease. Researchers will also monitor survival, drug levels in the body, and any immune reactions. Participants must undergo tumor tissue testing and have regular evaluations to track treatment effects and safety during the study period.
CONDITIONS
Brief 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.
- Male or female aged 18 to 75 years.
- ECOG performance status of 0 or 1.
- Diagnosed with locally advanced or metastatic triple negative breast cancer not suitable for radical therapy.
- Failed standard treatment or naive to systemic antitumor therapy in advanced setting.
- Must provide tumor tissue for testing.
- Life expectancy of at least 12 weeks.
- Must have measurable disease by RECIST version 1.1.
- Adequate organ function.
- Sexually active fertile participants and partners must agree to use contraception during the study and for 6 months after.
- Willing to follow study procedures.
You will not qualify if you...
- Preexisting treatment-related toxicity Grade 2 or higher and Grade 3 or higher immune-related adverse reactions.
- Preexisting peripheral neuropathy Grade 2 or higher.
- Hemoglobin A1C (HbA1c) of 8% or higher.
- Eye conditions increasing risk of corneal epithelium damage.
- History of interstitial lung disease (ILD), pneumonitis, severe uncontrolled disease, or central nervous system metastases.
- Recent chemotherapy or radiotherapy within 21 days (Cohort A).
- Recent immune checkpoint inhibitor or systemic immunosuppressive therapy within 14 days (Cohorts B and C).
- Use of traditional Chinese medicine with anticancer indication within 14 days.
- Use of investigational drug or device within 28 days.
- Prior treatment with nectin-4 targeted ADC with MMAE payload.
- Use of P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days.
- Major surgery within 28 days.
- 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.
- Active autoimmune disease requiring systemic treatment within 2 years.
- History of another malignancy within 3 years.
- Any other condition making participant unsuitable for study treatment as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive intravenous infusions of 9MW2821 alone or combined with a PD-1 inhibitor as per protocol to treat locally advanced or metastatic triple-negative breast cancer.
Repeated visits for drug infusion as scheduled by the study protocol
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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