Recruiting

Phase 1

BL-M14D1Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

Sponsor:

SystImmune Inc.

Code:

NCT07080242

Conditions

Small Cell Lung Cancer Metastatic or Locally Advanced

Neuroendocrine Cancer

Metastatic Neuroendocrine Prostate Cancer

Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma

Metastatic Advanced Merkel Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BL-M14D1

Study Details

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

Conditions

Small Cell Lung Cancer Metastatic or Locally Advanced

Neuroendocrine Cancer

Metastatic Neuroendocrine Prostate Cancer

Metastatic Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma

Metastatic Advanced Merkel Cell Carcinoma

Study ID

NCT07080242

Start date

Apr 28, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (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

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental BL-M14D1 administered Day 1 per cycle

BL-M14D1 will be administered on Day 1 by intravenous (IV) infusion every 3 weeks

Interventions

BL-M14D1

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

Primary outcome measure

Assess safety and tolerability of BL-M14D1 [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Lien Huzzy

4254536841 lien.huzzy@systimmune.com

Whitney Eakins

4254536841 whitney.eakins@systimmune.com

Locations

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Trenis Palmer, PhD

912-398-3205 trenis.palmer@vctcare.com

Principal Investigator:

David Berz, MD, PhD, MPH

University of Colorado - Anschutz Cancer Pavilion

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Melissa Cross, MPH

melissa.cross@cuanschutz.edu

Principal Investigator:

Tejas Patil, MD

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

Contacts

Kwasi Boateng, M.S., CCRP

203-314-7948 Kwasi.Boateng@yale.edu

Principal Investigator:

Pamela Kunz, MD

Emory Winship

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Winship CTO

404-778-1868 winshipcto@emory.edu

Principal Investigator:

Olatunji Alese, MD

John Theurer Cancer Center-Hackensack

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777 OncologyResearchReferral@hmhn.org

Principal Investigator:

Martin Gutierrez, MD

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Mohammad Ghalib, MBBS

732-609-2510 mhg68@cinj.rutgers.edu

Principal Investigator:

Sanjay Goel, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Deborah Doroshow, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43201

Principal Investigator:

Bhavana Konda, MD

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Isa Ngirailemesang

971-358-2056 isa.ngirailemesang@providence.org

Principal Investigator:

Rachel Sanborn, MD

Prisma Health Cancer Institute

Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator:

Jeffrey Edenfield, MD

NEXT Dallas

Recruiting

Dallas, Texas, United States, 75039

Contacts

Mofopefoluwa Akinwale

(972) 893-8800 fakinwale@nextoncology.com

Principal Investigator:

Michael Song, MD, PhD, PharmD

START Dallas- Fort Worth

Recruiting

Dallas, Texas, United States, 76104

Principal Investigator:

Henry Xiong, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Desirae Dufner

713-745-7813 ddufner@mdanderson.org

Principal Investigator:

Timothy Yap, MD

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912 emorales@nextoncology.com

Principal Investigator:

Jennifer Segar, MD

START- San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Drew Rasco, MD

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman, RN, BSN, OCN

703-636-1473 carrie.friedman@usoncology.com

Principal Investigator:

Alexander Spira

University of Washington/Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Samantha Kiriluk

206-606-7341 smlim3@fredhutch.org

Principal Investigator:

Shailender Bhatia, MD

More Information

Sponsor

SystImmune Inc.

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SystImmune Inc. on 2026-07-20.