Actively Recruiting
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Led by SystImmune Inc. · Updated on 2026-02-09
120
Participants Needed
20
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreed to follow trial requirements
- Age 18 years or older
- Weighs more than 40 kg
- Life expectancy of at least 3 months
- Documented locally advanced or metastatic small cell lung cancer, large cell neuroendocrine lung cancer, neuroendocrine prostate cancer, poorly differentiated gastroenteropancreatic neuroendocrine carcinomas, extrapulmonary neuroendocrine carcinomas, Merkel cell carcinoma, or other high-grade neuroendocrine neoplasms with DLL3 expression
- Failed at least one line of standard therapy in the advanced/metastatic setting or unable to receive standard treatment
- Agree to provide archival or fresh tumor tissue samples as specified
- At least one measurable lesion based on RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Previous therapy toxicity returned to Grade 1 or less, except for controlled alopecia and endocrinopathies
- No serious cardiac dysfunction and left ventricular ejection fraction of 50% or higher
- Adequate marrow, liver, and kidney function as defined
- Coagulation parameters within specified limits or on stable anticoagulation
- Urine protein 2+ or less or less than 1000 mg/24 hours
- Agree to use highly effective contraception if fertile and sexually active
- Women of childbearing potential must have a negative pregnancy test and not be lactating
- Women considered non-childbearing if permanently sterilized or postmenopausal with confirmed hormone levels
You will not qualify if you...
- Recent chemotherapy, biological therapy, immunotherapy, targeted therapy, radiotherapy, or major surgery within specified timeframes prior to first dose
- Prior topoisomerase inhibitor-based ADC therapy
- Use of strong CYP enzyme inhibitors or inducers
- History of severe heart disease or recent myocardial infarction or unstable angina
- Prolonged QT interval, certain heart conduction abnormalities, or risk factors for Torsades de Pointes
- Active autoimmune or inflammatory diseases requiring systemic treatment, except well-controlled conditions
- Other active or recent malignancies except certain skin cancers or those disease-free for at least 3 years
- Poorly controlled hypertension
- Advanced or significant lung diseases like poorly controlled COPD or asthma
- History or presence of interstitial lung disease or pneumonitis requiring treatment
- Recent stroke or transient ischemic attack
- Recent thromboembolic events unless stable on anticoagulation
- Active or untreated central nervous system malignancies or metastases unless stable
- Preexisting Grade 2 or higher peripheral neuropathy
- History of severe allergic reactions to humanized or chimeric antibodies or BL-M14D1 components
- Previous organ or stem cell transplantation
- Treatment with high-dose systemic glucocorticoids except for specific cases
- Known HIV infection unless meeting stability criteria
- Active hepatitis B or C infections unless controlled as specified
- Active or latent tuberculosis
- Active infections requiring intravenous antimicrobial treatment within one week before first dose
- Participation in another clinical trial within 4 weeks prior to first dose
- Pregnant or breastfeeding or planning pregnancy during the study
- Any other condition judged unsuitable by Investigator or Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
UCLA
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)
San Francisco, California, United States, 94158
Not Yet Recruiting
4
University of Colorado - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Not Yet Recruiting
5
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
Not Yet Recruiting
6
Emory Winship
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
University of Kentucky - Markey Cancer Center
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
8
John Theurer Cancer Center-Hackensack
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
10
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43201
Not Yet Recruiting
12
Providence Cancer Institute
Portland, Oregon, United States, 97213
Not Yet Recruiting
13
Prisma Health Cancer Institute
Greenville, South Carolina, United States, 29605
Not Yet Recruiting
14
NEXT Dallas
Dallas, Texas, United States, 75039
Not Yet Recruiting
15
START Dallas- Fort Worth
Dallas, Texas, United States, 76104
Not Yet Recruiting
16
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
NEXT Houston
Houston, Texas, United States, 77054
Not Yet Recruiting
18
START- San Antonio
San Antonio, Texas, United States, 78229
Not Yet Recruiting
19
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
20
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98195
Not Yet Recruiting
Research Team
L
Lien Huzzy
CONTACT
W
Whitney Eakins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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