RecruitingPhase 1NCT06503783

A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

20 participants

Start Date

Aug 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called BL-M17D1, which is an antibody-drug conjugate — a targeted therapy that delivers chemotherapy directly to cancer cells. It is being tested in patients with advanced or metastatic breast cancer (both HER2-positive and HER2-negative) and other solid tumors that have not responded to prior treatments. **You may be eligible if...** - You are 18–75 years old (or 18 and older for later stages of the study) - You have locally advanced or metastatic breast cancer or another solid tumor - You are in good general health and able to perform daily activities - Your organs (heart, liver, kidneys) are functioning adequately - You are not pregnant and willing to use contraception **You may NOT be eligible if...** - You have received chemotherapy or targeted therapy in the last 4 weeks - You have a history of severe heart disease - You have active brain metastases - You are pregnant or breastfeeding - You have uncontrolled infections or serious medical conditions 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-M17D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06503783


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