RecruitingPhase 2NCT06445400

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

120 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests BL-M07D1 — a new type of cancer treatment called an antibody-drug conjugate that targets HER2 — alone and in combination with other HER2-targeted therapies (pertuzumab and docetaxel) in patients with HER2-positive metastatic or advanced breast cancer. HER2-positive means the cancer cells have extra amounts of a protein that drives their growth. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed HER2-positive breast cancer that cannot be surgically removed or has spread - You have at least one measurable tumor on scans - You have not previously received systemic treatment for metastatic disease - Your heart, blood, liver, and kidney function are within acceptable levels **You may NOT be eligible if...** - You have received prior chemotherapy for your current stage of disease - You have active brain metastases or severe lung or heart conditions - You have HIV, active hepatitis B or C - You are pregnant or breastfeeding - You have a history of severe autoimmune disease or organ transplantation 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-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGPertuzumab

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGDocetaxel

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06445400


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