RecruitingPhase 1NCT05461768

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-M07D1injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expression Breast Cancer and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

26 participants

Start Date

Aug 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 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-M07D1 in patients


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing BL-M07D1, a new type of targeted drug called an antibody-drug conjugate (ADC), in people with HER2-positive or HER2-low metastatic breast cancer and other solid tumors. ADCs work like a guided missile — they attach to cancer cells and deliver chemotherapy directly to them. **You may be eligible if...** - You are 18–75 years old (or 18+ in later study phases) - You have advanced or metastatic HER2-positive or HER2-low breast cancer or another solid tumor - Your cancer has been confirmed by biopsy - Your cancer cannot be removed by surgery - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have untreated or active brain metastases - You have serious heart, liver, or lung problems - You have received certain prior treatments that overlap with this drug 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


Locations(7)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

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

Guangdong, Guangzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Jinan Central Hospital

Jinan, Shandong, China

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05461768


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