RecruitingPhase 1NCT06493864

A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumor


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

21 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called BL-B16D1 in people with advanced breast cancer or other solid tumors that cannot be surgically removed and have stopped responding to standard treatments. **You may be eligible if...** - You are 18–75 years old (or 18+ in later study phases) - You have advanced breast cancer or another solid tumor confirmed by biopsy - Your cancer cannot be removed by surgery and has stopped responding to standard treatment - You have at least one measurable tumor lesion - Your expected survival is at least 3 months - You can provide tumor tissue for testing **You may NOT be eligible if...** - You have uncontrolled cancer in the brain - You have severe organ dysfunction - You are pregnant or breastfeeding - You have had recent major surgery or other active cancer treatments 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-B16D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06493864


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