Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

Study summary

The objective of this study is 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBL-M14D1

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?SystImmune Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: SystImmune Inc.
Interventions being studied: Drug: BL-M14D1

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment
Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting.
No prior topoisomerase inhibitor-based ADC therapy is permitted.
In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgroup): participants will be eligible based on documented positive DLL3 expression.
At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy
No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
Adequate organ function

Reasons someone may not be able to joinExclusion criteria

Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
Participants who have received prior topoisomerase inhibitor-based ADC therapy
Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc.
Participants with primary neoplasms in the central nervous system (CNS), active or untreated CNS metastases, spinal cord compression, or carcinomatous meningitis should be excluded. Active brain metastases are defined as untreated symptomatic brain metastases or untreated brain metastases requiring systemic corticosteroids and/or anticonvulsants to control CNS-related symptoms. Patients with brain metastases are eligible if they meet any of the following criteria: 1. untreated, asymptomatic brain metastases 2. previously treated brain metastases may participate provided they are clinically stable with local therapy (eg, surgery or radiotherapy, currently asymptomatic, no longer requiring corticosteroid treatment, and recovered from all local therapy-related adverse events, as determined by the investigator
Participated in another clinical trial within 4 weeks prior to first dose of study treatment
Participants who are pregnant or breastfeeding, or planning to become pregnant during the study
Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Clearview Cancer InstituteHuntsville, Alabama
Los Alamitos Hematology/Oncology Medical GroupGlendale, California
MemorialCare Long Beach Medical CenterLong Beach, California
Valkyrie Clinical TrialsLos Angeles, California
UCLALos Angeles, California
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)San Francisco, California
University of Colorado - Anschutz Cancer PavilionAurora, Colorado
Yale Cancer CenterNew Haven, Connecticut
Emory WinshipAtlanta, Georgia
Tulane School of MedicineNew Orleans, Louisiana
START - New JerseyEast Brunswick, New Jersey
John Theurer Cancer Center-HackensackHackensack, New Jersey

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2026. Always confirm current availability with the study team.

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