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Small Cell Lung Cancer Metastatic or Locally AdvancedPhase 1NCT07080242

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

A Phase 1 study testing BL-M14D1 in people with Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer, run by SystImmune Inc. at 24 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BL-M14D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
24 sitesUnited States
Study dates
28 Apr 2025to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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:
  • untreated, asymptomatic brain metastases
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  • 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

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lien Huzzy contact

4254536841

lien.huzzy@systimmune.com

Whitney Eakins contact

4254536841

whitney.eakins@systimmune.com

24 sites in 1 country

United States24 sites, 24 recruiting

  • Emory Winship

    Atlanta, Georgia, 30322

    Winship CTO, 404-778-1868, winshipcto@emory.edu

    Olatunji Alese, MD

    Recruiting

  • University of Colorado - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

    Melissa Cross, MPH, melissa.cross@cuanschutz.edu

    Tejas Patil, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43201

    Bhavana Konda, MD

    Recruiting

  • NEXT Dallas

    Dallas, Texas, 75039

    Mofopefoluwa Akinwale, (972) 893-8800, fakinwale@nextoncology.com

    Michael Song, MD, PhD, PharmD

    Recruiting

  • START Dallas- Fort Worth

    Dallas, Texas, 76104

    Henry Xiong, MD

    Recruiting

  • START - New Jersey

    East Brunswick, New Jersey, 08816

    Danielle Schmidt, danielle.schmidt@startresearch.com

    Neel Belani, MD

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

    Carrie Friedman, RN, BSN, OCN, 703-636-1473, carrie.friedman@usoncology.com

    Alexander Spira

    Recruiting

  • Los Alamitos Hematology/Oncology Medical Group

    Glendale, California, 91203

    Heather Lyon, 818-254-2526, heatherl@opnhc.com

    Michael Nguyen

    Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

    Jeffrey Edenfield, MD

    Recruiting

  • John Theurer Cancer Center-Hackensack

    Hackensack, New Jersey, 07601

    Oncology Clinical Research Referral Office, 551-996-1777, OncologyResearchReferral@hmhn.org

    Martin Gutierrez, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Desirae Dufner, 713-745-7813, ddufner@mdanderson.org

    Timothy Yap, MD

    Recruiting

  • NEXT Houston

    Houston, Texas, 77054

    Emma Morales, 832-384-7912, emorales@nextoncology.com

    Jennifer Segar, MD

    Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

    Jorge Diaz, MD

    Not yet recruiting

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90806

    Shelbe Tolentino, 562-756-7625, STolentino2@memorialcare.org

    Nilesh Vora, MD

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Trenis Palmer, PhD, 912-398-3205, trenis.palmer@vctcare.com

    David Berz, MD, PhD, MPH

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Jenna Davis, 310-633-8400, JLDavis@mednet.ucla.edu

    Joel Hecht, MD

    Not yet recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

    Mohammad Ghalib, MBBS, 732-609-2510, mhg68@cinj.rutgers.edu

    Sanjay Goel, MD

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

    Kwasi Boateng, M.S., CCRP, 203-314-7948, Kwasi.Boateng@yale.edu

    Pamela Kunz, MD

    Recruiting

  • Tulane School of Medicine

    New Orleans, Louisiana, 70112

    Mark Sides, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Deborah Doroshow, MD

    Recruiting

  • Providence Cancer Institute

    Portland, Oregon, 97213

    Isa Ngirailemesang, 971-358-2056, isa.ngirailemesang@providence.org

    Rachel Sanborn, MD

    Recruiting

  • START- San Antonio

    San Antonio, Texas, 78229

    Drew Rasco, MD

    Recruiting

  • UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center)

    San Francisco, California, 94158

    Rahul Aggarwal, MD

    Not yet recruiting

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washington, 98195

    Samantha Kiriluk, 206-606-7341, smlim3@fredhutch.org

    Shailender Bhatia, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

Read the detailed description

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

Being tested
BL-M14D1
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M14D1Drug

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

Study groups in NCT07080242
Study groupRoleWhat they receive
Experimental BL-M14D1 administered Day 1 per cycleExperimentalBL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks
Receives: Drug: BL-M14D1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 months

Secondary outcomes (2)

  1. To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04)

    PK Endpoints: Serum concentration of BL-M14D1, total anti-DLL3 antibody, and free payload ED-04 vs time will be utilized, serum PK parameters will include Cmax, Tmax, AUC0-8, AUClast and, if possible, Kel, t1/2, CL, Vz, Vss of BL-M14D1, total anti-DLL-3 antibody, and Ed-04. These PK parameters will be calculated both after the first dose and after multiple doses if applicable.

    Measured: 18 months

  2. To investigate the antitumor activity of BL-M14D1

    • Tumor response evaluated using RECIST v1.1, ORR, DCR, DoR, TTR, and PFS
    • OS

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start28 Apr 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080242
Sponsor's protocol ID
BL-M14D1-ST-101
Status last verified
Sep 2026
First submitted
14 Jul 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BL-M14D1 in people with Small Cell Lung Cancer Metastatic or Locally Advanced and Neuroendocrine Cancer, run by SystImmune Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lien Huzzy (4254536841, lien.huzzy@systimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess safety and tolerability of BL-M14D1 (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07080242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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