RecruitingPhase 1NCT07056556

A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

31 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open-label, multicenter, dose-escalation and cohort-expansion, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests BL-M09D1, a new targeted drug (an antibody-drug conjugate) that delivers a cancer-killing agent directly to tumor cells, in people with advanced non-small cell lung cancer or other solid tumors that have stopped responding to standard treatments. The study aims to find the right dose and assess safety and effectiveness. **You may be eligible if...** - You are 18 or older with advanced non-small cell lung cancer or another solid tumor - Your cancer has progressed despite standard treatments - You have at least one measurable tumor on imaging - Your general health is good (ECOG 0–1) and your heart, liver, and kidney function meet requirements - You are willing to provide archived or fresh tumor tissue **You may NOT be eligible if...** - Your cancer has progressed too far or your health is too poor to tolerate treatment - You have significant heart problems (ejection fraction below 50%) - You are pregnant or breastfeeding - You have had recent serious side effects from prior cancer treatments that haven't resolved 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-M09D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07056556


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