RecruitingPhase 1NCT06505824

A Study of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-M14D1 in Patients With Locally Advanced or Metastatic Small Cell Lung Cancer, Neuroendocrine Tumors and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

22 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M14D1 in locally advanced or metastatic solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer drug called BL-M14D1 — an antibody-drug conjugate that delivers chemotherapy directly to cancer cells — in patients with advanced small cell lung cancer, neuroendocrine tumors, or other solid tumors that have no remaining standard treatment options. **You may be eligible if...** - You are 18–75 years old (or 18 and older for later study stages) - You have confirmed advanced or metastatic cancer with no effective standard treatment remaining - You are in good general health (ECOG 0 or 1) - Your organs (heart, liver, kidneys, blood) are functioning well enough to receive treatment - You are not pregnant and willing to use contraception **You may NOT be eligible if...** - You have had recent cancer treatment (within 4–6 weeks) - You have severe heart disease or poor cardiac function - You have active brain metastases that are symptomatic - You are pregnant or breastfeeding - You have uncontrolled infections or serious medical conditions 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-M14D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06505824


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