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New treatment option for Triple-Negative Breast Cancer
Official title A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06492005
What this study is testing
What is 9MW2821?
9MW2821 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved...
- Male or female people aged 18 to 75 years (including 18 and 75 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.
- people who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
You likely can't join if
- Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions
- Preexisting peripheral neuropathy Grade ≥ 2.
- Hemoglobin A1C (HbA1c) ≥ 8%.
- Has ocular conditions that may increase the risk of corneal epithelium damage.
- History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A). Received immune checkpoint inhibitor or systemic...
See the full eligibility criteria
- Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- Male or female people aged 18 to 75 years (including 18 and 75 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.
- people who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
- people must submit tumor tissues for test.
- Life expectancy of ≥ 12 weeks.
- people must have measurable disease according to RECIST (version 1.1).
- Adequate organ functions.
- Sexually active fertile people, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- people are willing to follow study procedures
- Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions
- Preexisting peripheral neuropathy Grade ≥ 2.
- Hemoglobin A1C (HbA1c) ≥ 8%.
- Has ocular conditions that may increase the risk of corneal epithelium damage.
- History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A). Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first...
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug
- Active autoimmune disease requiring systemic treatment within 2 years before the subject's first study medication.
- History of another malignancy within 3 years before the first dose of study drug.
- Not suitable to receive study treatment for other conditions as per investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.