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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

• 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Jian Zhang, Professor
syner2000@163.com
13918273761
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2027-07
Participants
Target number of participants: 160
Treatments
Experimental: Treatment Cohort A:9MW2821
Drug:9MW2821
Experimental: Treatment Cohort B:9MW2821+PD-1 inhibitior
Drug: 9MW2821,PD-1 inhibitior
Experimental: Treatment Cohort C:9MW2821 ±PD-1 inhibitior
Drug: 9MW2821,PD-1 inhibitior
Related Therapeutic Areas
Sponsors
Leads: Mabwell (Shanghai) Bioscience Co., Ltd.

This content was sourced from clinicaltrials.gov