Triple-Negative Breast CancerPhase 2NCT06492005
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Phase 2 study testing 9MW2821 and PD-1 inhibitior in people with Triple-Negative Breast Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple-Negative Breast Cancer
- What is being tested?
- 9MW2821 and PD-1 inhibitior
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2024to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 subjects 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.
- Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
- Subjects must submit tumor tissues for test.
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- Life expectancy of ≥ 12 weeks.
- Subjects must have measurable disease according to RECIST (version 1.1).
- Adequate organ functions.
- 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.
- Subjects are willing to follow study procedures
Who cannot join
- 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 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..
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, Professor, syner2000@163.com
Jian Zhang, Professor
About this study
Official title: A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer
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
- Triple-Negative Breast Cancer
- Being tested
- 9MW2821, PD-1 inhibitior
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW2821Drug
Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
PD-1 inhibitiorDrug
Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort A:9MW2821 | Experimental | Drug：9MW2821 Receives: Drug: 9MW2821 |
| Treatment Cohort B:9MW2821+PD-1 inhibitior | Experimental | Drug: 9MW2821,PD-1 inhibitior Receives: Drug: 9MW2821; Drug: PD-1 inhibitior |
| Treatment Cohort C:9MW2821 ±PD-1 inhibitior | Experimental | Drug: 9MW2821,PD-1 inhibitior Receives: Drug: 9MW2821; Drug: PD-1 inhibitior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
ORR
Measured: Up to 24 months
Secondary outcomes (10)
Duration of Response
DoR
Measured: Up to 24 months
Time to Response
TTR
Measured: Up to 24 months
Disease Control Rate
DCR
Measured: Up to 24 months
Progression Free Survival
PFS
Measured: Up to 24 months
Overall Survival
OS
Measured: Up to 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Maximum observed concentration (Cmax)
Measured: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Area under the concentration-time curve (AUC)
Measured: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Half-life (t1/2)
Measured: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Clearance (CL)
Measured: 24 months
Incidence of Anti-Drug Antibody (ADA)
ADA
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start26 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492005
- Sponsor's protocol ID
- 9MW2821-CP205
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06492005
- Acronym / sponsor ID
- 9MW2821-CP205
- Conditions
- Triple-Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort A:9MW2821 | Experimental | Drug: 9MW2821Drug：9MW2821 |
| Treatment Cohort B:9MW2821+PD-1 inhibitior | Experimental | Drug: 9MW2821, Drug: PD-1 inhibitiorDrug: 9MW2821,PD-1 inhibitior |
| Treatment Cohort C:9MW2821 ±PD-1 inhibitior | Experimental | Drug: 9MW2821, Drug: PD-1 inhibitiorDrug: 9MW2821,PD-1 inhibitior |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 subjects 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.
- Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW2821Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol | Drug | Treatment Cohort A:9MW2821, Treatment Cohort B:9MW2821+PD-1 inhibitior, Treatment Cohort C:9MW2821 ±PD-1 inhibitior |
| PD-1 inhibitiorSubjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol | Drug | Treatment Cohort B:9MW2821+PD-1 inhibitior, Treatment Cohort C:9MW2821 ±PD-1 inhibitior |
Primary outcome
Objective Response Rate
Time frame: Up to 24 months
ORR
10 secondary outcomes
Duration of Response
Time frame: Up to 24 months
Time to Response
Time frame: Up to 24 months
Disease Control Rate
Time frame: Up to 24 months
Progression Free Survival
Time frame: Up to 24 months
Overall Survival
Time frame: Up to 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Time frame: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Time frame: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Time frame: 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Time frame: 24 months
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 9MW2821 and PD-1 inhibitior in people with Triple-Negative Breast Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, Professor (13918273761, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.