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Trial Title:
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT ID:
NCT06492005
Condition:
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
9MW2821
Description:
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Arm group label:
Treatment Cohort A:9MW2821
Arm group label:
Treatment Cohort B:9MW2821+PD-1 inhibitior
Arm group label:
Treatment Cohort C:9MW2821 ±PD-1 inhibitior
Intervention type:
Drug
Intervention name:
PD-1 inhibitior
Description:
Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol
Arm group label:
Treatment Cohort B:9MW2821+PD-1 inhibitior
Arm group label:
Treatment Cohort C:9MW2821 ±PD-1 inhibitior
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Competent to comprehend, sign, and date an independent ethics
committee/institutional review board/research ethics board (IEC/IRB/REB) approved
informed consent form.
2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histopathological diagnosed of locally advanced or metastatic triple negative breast
cancer. Not suitable for radical therapy.
5. Subjects who have failed standard treatment or naive to systemic antitumor therapy
in advanced setting.
6. Subjects must submit tumor tissues for test.
7. Life expectancy of ≥ 12 weeks.
8. Subjects must have measurable disease according to RECIST (version 1.1).
9. Adequate organ functions.
10. Sexually active fertile subjects, and their partners, must agree to use methods of
contraception during the study and at least 6 months after termination of study
therapy.
11. Subjects are willing to follow study procedures
Exclusion Criteria:
1. Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related
adverse reactions
2. Preexisting peripheral neuropathy Grade ≥ 2.
3. Hemoglobin A1C (HbA1c) ≥ 8%.
4. Has ocular conditions that may increase the risk of corneal epithelium damage.
5. History of ILD or pneumotitis, other severe or uncontrolled disease or central
nervous system metastases.
6. 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 study (Cohort B and C).
traditional Chinese medicine with anticancer indication within 14 days prior to the
first dose of study drug, use of any investigational drug or device within 28 days
prior to the first dose of study drug, received treatment of nectin-4 targeted ADC
with MMAE payload, any P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4
inducers/inhibitors within 14 days prior to the first dose of study drug, major
surgery within 28 days prior to first dose of study drug or any live vaccines within
28 days before first dose of study drug or during the study..
7. History of allogeneic hematopoietic stem cell transplantation or solid organ
transplantation;
8. Known sensitivity to any of the ingredients of the investigational product; History
of drug abuse or mental illness.
9. Documented history of pulmonary embolism or clinically significant cardiac or
cerebrovascular diseases within 6 months prior to the first dose of study drug
10. Active autoimmune disease requiring systemic treatment within 2 years before the
subject's first study medication.
11. History of another malignancy within 3 years before the first dose of study drug.
12. Not suitable to receive study treatment for other conditions as per investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 2024
Completion date:
July 2027
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06492005
