RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BL-M14D1 for small cell lung cancer and certain neuroendocrine cancers, which start in cells with nerve and hormone-making features. It is for people whose cancer has grown nearby or spread to other parts of the body. The study checks how safe the drug is, how the body handles it, and how well it works.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have small cell lung cancer or one of the listed neuroendocrine cancers that has grown nearby or spread. Some cancer types must test positive for a protein called DLL3.
  • Have tried at least one standard treatment for advanced cancer that did not work, or be unable to receive standard treatment. For small cell lung cancer, a platinum-based treatment must have failed.
  • For the study’s DLL3-positive group, have a test showing DLL3 in the cancer.
  • Have at least one tumor that can be measured using the study’s rules.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Side effects from past cancer treatment must be mild or gone, except hair loss or hormone problems controlled with replacement medicines.
  • Have no serious heart problems. The heart’s main pumping chamber must pump out at least 50% of its blood with each beat.
  • Have organs that work well enough for the study.

Who can't join

  • Have had cancer treatment too recently. Waiting times vary by treatment, usually from 2 to 6 weeks; major surgery requires 4 weeks. The study team will check the exact timing.
  • Have previously received an antibody-drug conjugate, a drug linked to an antibody, that contains a topoisomerase inhibitor.
  • Have another past or current cancer, except certain skin cancers or cancers removed before spreading, or cancer treated to cure it with at least 3 years cancer-free.
  • Have serious lung disease, such as poorly controlled asthma or COPD, lung disease that limits breathing, or high blood pressure in the lungs.
  • Have cancer starting in the brain or spinal cord, pressure on the spinal cord, or cancer in their lining. Brain spread may be allowed if untreated with no symptoms, or treated and stable with no symptoms, no need for steroids, and recovery from local treatment side effects.
  • Have joined another clinical trial within 4 weeks before the first study dose.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have another condition that the study doctor or sponsor believes makes this study unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (24)

AL

CA

CO

CT

GA

LA

NJ

NY

  • Icahn School of Medicine at Mount Sinai · New York, NY 10029Deborah Doroshow, MD · Principal investigatorMore trials in New York

OH

OR

SC

  • Prisma Health Cancer Institute · Greenville, SC 29605Jeffrey Edenfield, MD · Principal investigatorMore trials in Greenville

TX

VA

WA