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

This study is testing a drug called BL-M14D1 for people with locally advanced or metastatic (spread to other parts of the body) small cell lung cancer and other neuroendocrine tumors. This includes conditions like large cell neuroendocrine cancer of the lung, neuroendocrine prostate cancer, and Merkel cell carcinoma. The main goal of this study is to see how safe BL-M14D1 is and how well people tolerate it over 18 months. BL-M14D1 is designed to work as an antibody-drug conjugate (ADC), immunotherapy, and targeted therapy. You may be able to join if you are 18 or older and have one of the specified types of cancer. The current status of this study is unclear.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 120 participants.
What's involved
BL-M14D1 will be given on Day 1 every 3 weeks. Specific details about other visits or procedures are not provided.
Compensation
Not stated in the trial record.
Follow-up
The safety and tolerability of BL-M14D1 will be assessed over 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07080242

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SystImmune Inc.
~120 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:BL-M14D1

At a glance

Recruiting sites
17 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess safety and tolerability of BL-M14D1
Measured over 18 months

Conditions

Small Cell Lung Cancer Metastatic or Locally Advanced
Neuroendocrine Cancer
Metastatic Neuroendocrine Prostate Cancer
Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
Metastatic Advanced Merkel Cell Carcinoma
Locally Advanced Large Cell Neuroendocrine Carcinoma of the Lung
Locally Advanced Extrapulmonary Neuroendocrine Carcinoma
Locally Advanced Neuroendocrine Prostate Cancer
Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine
Locally Advanced Merkel Cell Carcinoma
Metastatic Large Cell Neuroendocrine Carcinoma of the Lung

Explore related trials

Extrapulmonary Neuroendocrine CarcinomaGastroenteropancreatic Neuroendocrine CarcinomaLung Large Cell Neuroendocrine CarcinomaLung Small Cell CarcinomaMerkel Cell CarcinomaNeuroendocrine Composite HemangioendotheliomaProstate Neuroendocrine CarcinomaDLL3 Gene

Where it's being run

20 sites across 13 states
Texas5
California3
New Jersey2
Alabama1
Colorado1
Connecticut1
Georgia1
New York1

Study leadership

  • Rishi Jain · STUDY_DIRECTOR · SystImmune Inc.

Who to contact

Lien Huzzy
[email protected]
4254536841
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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 (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.
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

What this trial measures

  • Assess safety and tolerability of BL-M14D118 months

    SAEs, AESIs, TEAEs, death, TEAEs leading to discontinuation, DLTs, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, ECG parameters (including the change-from-baseline ECG parameters), and ECHO/MUGA findings