Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
A Phase 1 Open-Label Study 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
1 other identifier
interventional
120
1 country
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2025
CompletedFirst Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 20, 2026
July 1, 2026
2.7 years
July 14, 2025
July 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Assess safety and tolerability of BL-M14D1
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
18 months
Secondary Outcomes (2)
To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04)
18 months
To investigate the antitumor activity of BL-M14D1
18 months
Study Arms (1)
Experimental BL-M14D1 administered Day 1 per cycle
EXPERIMENTALBL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks
Interventions
BL-M14D1 will be administered on D1 every 3 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SystImmune Inc.lead
Study Sites (20)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
UCLA
Los Angeles, California, 90095, United States
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)
San Francisco, California, 94158, United States
University of Colorado - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
Emory Winship
Atlanta, Georgia, 30322, United States
John Theurer Cancer Center-Hackensack
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Ohio State University
Columbus, Ohio, 43201, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605, United States
NEXT Dallas
Dallas, Texas, 75039, United States
START Dallas- Fort Worth
Dallas, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Houston
Houston, Texas, 77054, United States
START- San Antonio
San Antonio, Texas, 78229, United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031, United States
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rishi Jain
SystImmune Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 23, 2025
Study Start
April 28, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 20, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share