RecruitingPhase 2NCT07264816

A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a targeted drug (BL-M07D1, an antibody-drug conjugate that targets the HER2 protein) plus an immunotherapy drug (pembrolizumab) in people with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that overexpresses the HER2 protein. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic non-squamous NSCLC - Your tumor has been confirmed to overexpress the HER2 protein - You have at least one measurable tumor on imaging - You are in good enough health to carry out daily activities - Your heart function is normal (ejection fraction ≥50%) **You may NOT be eligible if...** - You have received HER2-targeted therapy or antibody-drug conjugates using similar components before - Your cancer has spread to the brain or spinal fluid - You have had a serious heart attack, stroke, or significant heart problem in the past 6 months - You have active autoimmune disease, interstitial lung disease, or active hepatitis B, C, or HIV - You are pregnant or breastfeeding - You have had surgery, radiation, or immunotherapy within 4 weeks before the study 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 for a cycle of 3 weeks.

DRUGPembrolizumab

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07264816


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