RecruitingPhase 1Phase 2NCT06114511

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

98 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BL-M07D1 in patients with non-small cell lung cancer (NSCLC) that carries a HER2 mutation — a specific genetic change that affects how cancer cells grow. HER2-mutated lung cancer is hard to treat with standard therapies. **You may be eligible if:** - You are between 18 and 75 years old - You have confirmed advanced or metastatic non-small cell lung cancer that cannot be surgically removed - Your tumor has a known HER2-sensitizing mutation - You have received at least one prior line of treatment - Your expected survival is at least 3 months - Your organ function (heart, liver, kidneys) is adequate **You may NOT be eligible if:** - Your cancer does not have a HER2 mutation - You have received a prior anti-HER2 drug that is in the same class as BL-M07D1 - You have active brain metastases or other serious conditions - 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-M07D1

Administration by intravenous infusion


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06114511


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