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Clinical Trials in the USA / NCT07080242
Recruiting Phase 1

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

NCT07080242 · tracked via the Priya Life Science USA tracker
Sponsor
SystImmune Inc.
Phase
Phase 1
Started
2025-04-28
Last updated
2026-09-16

Condition(s) studied

Small Cell Lung Cancer Metastatic or Locally AdvancedNeuroendocrine CancerMetastatic Neuroendocrine Prostate CancerMetastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine CarcinomaMetastatic Advanced Merkel Cell CarcinomaLocally Advanced Large Cell Neuroendocrine Carcinoma of the LungLocally Advanced Extrapulmonary Neuroendocrine CarcinomaLocally Advanced Neuroendocrine Prostate CancerLocally Advanced Poorly Differentiated Gastroenteropancreatic NeuroendocrineLocally Advanced Merkel Cell CarcinomaMetastatic Large Cell Neuroendocrine Carcinoma of the Lung

Investigational drug(s) / intervention(s)

BL-M14D1

BL-M14D1: BL-M14D1 will be administered on D1 every 3 weeks.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Not Yet Recruiting
Los Alamitos Hematology/Oncology Medical Group Glendale California Recruiting
MemorialCare Long Beach Medical Center Long Beach California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
UCLA Los Angeles California Not Yet Recruiting
UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center) San Francisco California Not Yet Recruiting
University of Colorado - Anschutz Cancer Pavilion Aurora Colorado Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Emory Winship Atlanta Georgia Recruiting
Tulane School of Medicine New Orleans Louisiana Recruiting
START - New Jersey East Brunswick New Jersey Recruiting
John Theurer Cancer Center-Hackensack Hackensack New Jersey Recruiting
Rutgers Cancer Institute New Brunswick New Jersey Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Ohio State University Columbus Ohio Recruiting
Providence Cancer Institute Portland Oregon Recruiting
Prisma Health Cancer Institute Greenville South Carolina Recruiting
NEXT Dallas Dallas Texas Recruiting
START Dallas- Fort Worth Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Houston Houston Texas Recruiting
START- San Antonio San Antonio Texas Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting
University of Washington/Fred Hutchinson Cancer Center Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07080242 on ClinicalTrials.gov ↗ ← All trials in the USA