RecruitingPhase 1NCT05262491

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor

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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

96 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.


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 people with advanced solid tumors — including triple-negative breast cancer — that have not responded to standard treatments. The drug targets a protein on the surface of cancer cells called TROP2. **You may be eligible if...** - You are between 18 and 75 years old (for Phase Ia) or 18 or older (for Phase Ib) - You have been diagnosed with locally advanced or metastatic triple-negative breast cancer or another solid tumor - Your cancer has stopped responding to standard therapies or you are not eligible for them - You are willing to provide a tumor tissue sample - You are expected to survive at least 3 months **You may NOT be eligible if...** - You have active brain metastases that are untreated or unstable - You have uncontrolled infections or serious heart or lung conditions - You are pregnant or breastfeeding - You have had recent major surgery or radiotherapy 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(6)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jinan Central Hospital

Jinan, Shandong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05262491


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