Recruiting

BL-M14D1 for Advanced Small Cell Lung Cancer and Neuroendocrine Tumors

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Study Aim

This study aims to evaluate the safety and determine the best dose of the new drug BL-M14D1 for treating adults with advanced small cell lung cancer and neuroendocrine tumors.

What is being tested

BL-M14D1

Drug
Who is being recruted

Bronchial Neoplasms+12

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 75 Years
+40 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorSichuan Baili Pharmaceutical Co., Ltd.
Study ContactSa Xiao, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 2, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new drug, BL-M14D1, in patients who have advanced stages of small cell lung cancer, neuroendocrine tumors, or other solid tumors. The goal is to understand how safe and tolerable this medication is when given to patients, as well as how it behaves in the body and whether it can help fight these cancers. This study is important because it may offer new hope for patients with these challenging conditions by potentially providing a new treatment option. Participants in this study receive BL-M14D1, with doses being adjusted to find the most effective and safest amount. The study does not involve random assignment, so all participants receive the treatment. Researchers closely monitor how the drug moves and acts in the body, while also watching for any side effects. Though this is an initial phase trial primarily focused on safety, it also looks at whether BL-M14D1 shows any signs of effectiveness against the cancer, offering valuable insights for future studies.

Official TitleA 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
NCT06505824
Principal SponsorSichuan Baili Pharmaceutical Co., Ltd.
Study ContactSa Xiao, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeuroectodermal TumorsNeuroendocrine TumorsSmall Cell Lung Carcinoma

Criteria

14 inclusion criteria required to participate
Voluntarily sign the informed consent and follow the requirements of the protocol;
No gender limit;
Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
Expected survival time ≥3 months;
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26 exclusion criteria prevent from participating
Anti-tumor therapy such as chemotherapy or biological therapy has been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
Prior receipt of an ADC drug with a TOPI inhibitor as a toxin;
History of severe heart disease or cerebrovascular disease;
QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive BL-M14D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai East Hospital

Shanghai, ChinaOpen Shanghai East Hospital in Google Maps
Recruiting
One Study Center