New drug BL-M14D1 targets tough cancers in early human trial
NCT ID NCT07080242
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times
Summary
This early-stage trial is testing a new drug called BL-M14D1 in about 120 people with advanced small cell lung cancer or other neuroendocrine cancers that have spread or cannot be removed. The drug works by homing in on a protein called DLL3 found on these cancer cells and delivering a chemotherapy agent directly to them. The main goals are to check the drug's safety and find the right dose, while also looking for early signs that it might shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BL-M14D1 (a drug that targets a protein called DLL3 on cancer cells and delivers a chemotherapy payload)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced small cell lung cancer or other neuroendocrine cancers that have stopped responding to standard therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 120 participants, so the drug may turn out to be unsafe or not effective. Side effects from the chemotherapy payload could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
24 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clearview Cancer Institute
NOT_YET_RECRUITINGHuntsville, Alabama, 35805, United States
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Emory Winship
RECRUITINGAtlanta, Georgia, 30322, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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John Theurer Cancer Center-Hackensack
RECRUITINGHackensack, New Jersey, 07601, United States
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Los Alamitos Hematology/Oncology Medical Group
RECRUITINGGlendale, California, 91203, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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MemorialCare Long Beach Medical Center
RECRUITINGLong Beach, California, 90806, United States
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NEXT Dallas
RECRUITINGDallas, Texas, 75039, United States
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NEXT Houston
RECRUITINGHouston, Texas, 77054, United States
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NEXT Oncology Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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Ohio State University
RECRUITINGColumbus, Ohio, 43201, United States
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Prisma Health Cancer Institute
RECRUITINGGreenville, South Carolina, 29605, United States
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Providence Cancer Institute
RECRUITINGPortland, Oregon, 97213, United States
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Rutgers Cancer Institute
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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START - New Jersey
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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START Dallas- Fort Worth
RECRUITINGDallas, Texas, 76104, United States
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START- San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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Tulane School of Medicine
RECRUITINGNew Orleans, Louisiana, 70112, United States
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UCLA
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)
NOT_YET_RECRUITINGSan Francisco, California, 94158, United States
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University of Colorado - Anschutz Cancer Pavilion
RECRUITINGAurora, Colorado, 80045, United States
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University of Washington/Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98195, United States
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Valkyrie Clinical Trials
RECRUITINGLos Angeles, California, 90067, United States
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Yale Cancer Center
RECRUITINGNew Haven, Connecticut, 06520-8028, United States
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Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Proton beams aimed at lung tumors while sparing the heart
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer