RecruitingPhase 2NCT06471205

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

52 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — BL-B01D1 (a targeted drug-antibody combination) and a PD-1 immune checkpoint inhibitor — in people with triple-negative breast cancer (a type with no hormone or HER2 receptors) that cannot be surgically removed or has spread. **You may be eligible if...** - You are 18 to 75 years old with triple-negative breast cancer confirmed by biopsy - Your cancer is locally advanced, recurrent, or has spread to other organs and cannot be removed by surgery - You have not had previous systemic treatment for advanced or metastatic disease - You have at least one measurable tumor - Your ECOG score is 0 or 1 - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have received prior chemotherapy for advanced triple-negative disease - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.

DRUGPD-1 Monoclonal Antibody

Administration by intravenous infusion for a cycle of 3 weeks (Q3W).


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06471205


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