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

RECRUITINGPHASE1

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

NCT06505824•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent and follow the requirements of the protocol;
•2. No gender limit;
•3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
•4. Expected survival time ≥3 months;
•5. Histologically and/or cytologically confirmed locally advanced or metastatic solid tumors that are incurable or currently have no standard treatment;
•6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
•7. Must have at least one measurable lesion according to RECIST v1.1 definition;
•8. ECOG 0 or 1;
•9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
•10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
+4 more criteria

Exclusion Criteria

•1. 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;
•2. Prior receipt of an ADC drug with a TOPI inhibitor as a toxin;
•3. History of severe heart disease or cerebrovascular disease;
•4. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
•5. Active autoimmune and inflammatory diseases;
•6. Other malignant tumors diagnosed within 5 years before the first dose;
•7. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
•8. A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition, or suspicion of such a condition during screening;
•9. Complicated pulmonary diseases leading to clinically severe respiratory function impairment;
•10. Patients with massive or symptomatic effusions or poorly controlled effusions;
+16 more criteria

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 2, 2024

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

September 18, 2025

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung CancerNeuroendocrine Tumors

Interventions

BL-M14D1

DRUG

Contacts

Sa Xiao, PHD

CONTACT

15013238943 xiaosa@baili-pharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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