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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

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

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

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

• Voluntarily sign the informed consent and follow the requirements of the protocol;

• Age: ≥18 years old and ≤75 years old;

• Expected survival time ≥3 months;

• ECOG 0 or 1;

• Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;

• Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;

• A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;

• Must have at least one place in accordance with RECIST v1.1 define measurable lesions;

• No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;

⁃ Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;

⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Sa Xiao, PHD
xiaosa@baili-pharm.com
15013238943
Time Frame
Start Date: 2024-08-02
Estimated Completion Date: 2028-06
Participants
Target number of participants: 52
Treatments
Experimental: BL-B01D1+PD-1 Monoclonal Antibody
Participants receive BL-B01D1+PD-1 Monoclonal Antibody as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Related Therapeutic Areas
Sponsors
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Leads: Sichuan Baili Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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