A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: 9MW2821; Drug: PD-1 inhibitior

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jian Zhang, Professor; Phone Number: 13918273761; Email: syner2000@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Principal Investigator: Jian Zhang, Professor
      • Contact: Jian Zhang, Professor; Email: syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Cohort A:9MW2821; Drug：9MW2821	Drug: 9MW2821; Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
Experimental: Treatment Cohort B:9MW2821+PD-1 inhibitior; Drug: 9MW2821,PD-1 inhibitior	Drug: 9MW2821; Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol; Drug: PD-1 inhibitior; Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol
Experimental: Treatment Cohort C:9MW2821 ±PD-1 inhibitior; Drug: 9MW2821,PD-1 inhibitior	Drug: 9MW2821; Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol; Drug: PD-1 inhibitior; Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	ORR	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Maximum observed concentration (Cmax)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Area under the concentration-time curve (AUC)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Half-life (t1/2)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Clearance (CL)	24 months
Disease Control Rate	DCR	Up to 24 months
Duration of Response	DoR	Up to 24 months
Time to Response	TTR	Up to 24 months
Progression Free Survival	PFS	Up to 24 months
Overall Survival	OS	Up to 24 months
Incidence of Anti-Drug Antibody (ADA)	ADA	Up to 24 months

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 9MW2821-CP205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No