Tests BL-M14D1 in adults with advanced lung and neuroendocrine cancers
Tests the drug BL-M14D1 in adults with advanced small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Key facts
- Where
- Batumi, Kutaisi, and Tbilisi, GeorgiaSee the 5 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with small cell lung cancer or another neuroendocrine cancer that is locally advanced or has spread. The cancer must have worsened after at least 1 line of standard treatment, or standard treatment must not be possible.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Locally advanced or metastatic small cell lung cancer, large cell neuroendocrine cancer of the lung, neuroendocrine prostate cancer, poorly differentiated neuroendocrine carcinoma of the gut or pancreas, other neuroendocrine carcinomas outside the lung, or Merkel cell carcinoma. At least one measurable tumour is needed.
- Earlier treatment
- At least 1 line of standard therapy for advanced or metastatic disease must have failed, or standard treatment is not possible. For small cell lung cancer, at least 1 line of platinum therapy must have failed. No earlier ADC therapy based on a topoisomerase inhibitor.
- Biomarker or test result
- Evidence of DLL3 expression in the tumour.
Main reasons for not taking part
- Earlier ADC therapy based on a topoisomerase inhibitor
- Another cancer now or before, with a few exceptions such as some skin cancers
- Active or untreated cancer in the brain or spinal cord, or cancer in the membranes around the brain
- Serious lung disease such as poorly controlled COPD, asthma or pulmonary hypertension
- Pregnant or breastfeeding, or planning pregnancy during the study
Read by machine on 9 November 2026.
Where in Georgia
- LTD High Technology Hospital MedcenterBatumi, GeorgiaNot yet recruiting
- JSC VianKutaisi, GeorgiaNot yet recruiting
- LLC "Caucasus Medical Centre"Tbilisi, GeorgiaTaking people
- LTD "New Hospitals"Tbilisi, GeorgiaNot yet recruiting
- LTD "Pineo Medical Ecosystem"Tbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SystImmune Inc.
- Trial code
- NCT07080242
- Record updated
- 30 October 2026
- Original description
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 NeoplasmsRead full original descriptionShow less
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
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
Inclusion: 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: 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 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:; untreated, asymptomatic brain metastases; 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 with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc; Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial; Participants who are pregnant or breastfeeding, or planning to become pregnant during the study.