RecruitingPhase 1NCT05470348

A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

36 participants

Start Date

Aug 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug combination called BL-B01D1 in patients with advanced or metastatic non-small cell lung cancer or other solid tumors that have not responded to previous treatments. **You may be eligible if...** - You have advanced non-small cell lung cancer or another solid tumor cancer that has stopped responding to standard therapy - Your cancer has measurable tumors on imaging - You are in reasonably good overall health despite your cancer **You may NOT be eligible if...** - You have certain uncontrolled infections or serious immune conditions - You have brain metastases that are not stable - You have severe heart, liver, or lung disease - 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


Locations(2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05470348


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