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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT07080242

Run by

SystImmune Inc.

People needed

120

Starts

2025-04-28

Expected to finish

2027-12-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington/Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
• NEXT Houston — Houston, Texas, United States (enrolling)
• START- San Antonio — San Antonio, Texas, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)
• University of Colorado - Anschutz Cancer Pavilion — Aurora, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Emory Winship — Atlanta, Georgia, United States (enrolling)
• John Theurer Cancer Center-Hackensack — Hackensack, New Jersey, United States (enrolling)
• Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Providence Cancer Institute — Portland, Oregon, United States (enrolling)
• Prisma Health Cancer Institute — Greenville, South Carolina, United States (enrolling)
• NEXT Dallas — Dallas, Texas, United States (enrolling)
• START Dallas- Fort Worth — Dallas, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• UCLA — Los Angeles, California, United States
• UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center) — San Francisco, California, United States
• Clearview Cancer Institute — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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