Recruiting

BL-M14D1 Safety, Tolerability, and Efficacy in Small Cell Lung Cancer and Neuroendocrine Neoplasms

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Study Aim

This phase 1 study aims to evaluate the safety, tolerability, and effectiveness of BL-M14D1 in individuals with Small Cell Lung Cancer and Neuroendocrine Neoplasms, while also determining the maximum tolerated dose.

What is being tested

BL-M14D1

Drug
Who is being recruted

Adenocarcinoma+11

+ Carcinoma

+ Neoplasm Metastasis

From 18 to 85 Years
+39 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorSystImmune Inc.
Study ContactLien HuzzyMore contacts
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 28, 2025

Actual date on which the first participant was enrolled.

This clinical trial is a phase 1 study that focuses on evaluating the safety, tolerability, and effectiveness of a drug called BL-M14D1. The study involves individuals diagnosed with locally advanced or metastatic small cell lung cancer and other neuroendocrine neoplasms. The main goal is to understand how the drug affects these patients and how well it can help manage their condition. The study also aims to determine the maximum tolerated dose or the maximum administered dose of BL-M14D1. During the trial, participants will receive BL-M14D1, and researchers will monitor various aspects of their health. This includes changes in daily activity levels, physical activity, and the ability to care for themselves. They will also track any abnormalities in ECG and ECHO/MUGA readings, lab results, and physical examination findings. The study will record any serious adverse events or treatment-emergent adverse events. The number of participants experiencing dose-limiting toxicities will also be measured. The results will help determine the appropriate dosage and potential benefits or risks associated with BL-M14D1.

Official TitleA Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms
NCT07080242
Principal SponsorSystImmune Inc.
Study ContactLien HuzzyMore contacts
Last updated: February 10, 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

120 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 85 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

AdenocarcinomaCarcinomaNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeuroectodermal TumorsCarcinoma, NeuroendocrineNeuroendocrine Tumors

Criteria

15 inclusion criteria required to participate
Agree to provide archival tumor samples (formalin-fixed paraffin-embedded [FFPE] tissue block or 6-12 slides of 5-μm thickness) from primary or metastatic sites
Signed the informed consent form voluntarily and agreed to follow the trial requirements
Life expectancy of ≥3 months
Urine protein ≤2+ or ≤1000 mg/24 hours
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24 exclusion criteria prevent from participating
Participants who have received prior topoisomerase inhibitor-based ADC therapy
Participants with a thromboembolic event (eg, deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months before screening except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before screening
Participants who are receiving treatment with systemic glucocorticoids >10 mg/day equivalent of prednisone, except for the treatment of COPD, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg/day equivalent of prednisone) is permitted. The use of topical, inhaled, and locally injected steroids is permitted
Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no radiological evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to screening.
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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 in this group will receive the experimental drug, BL-M14D1, through an IV on Day 1 of every 3-week cycle.

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 20 locations

Recruiting

Valkyrie Clinical Trials

Los Angeles, United StatesOpen Valkyrie Clinical Trials in Google Maps
Recruiting

Emory Winship

Atlanta, United States
Recruiting

John Theurer Cancer Center-Hackensack

Hackensack, United States
Recruiting

MD Anderson Cancer Center

Houston, United States
Recruiting
20 Study Centers