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NCT07080242PHASE1Recruiting

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

SystImmune Inc.

Start Date

4/28/2025

Completion Date

12/31/2027

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

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

BL-M14D1

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Conditions

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

Locations

Clearview Cancer Institute

Huntsville, Alabama 35805

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

UCLA

Los Angeles, California 90095

United States

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

San Francisco, California 94158

United States

University of Colorado - Anschutz Cancer Pavilion

Aurora, Colorado 80045

United States

Yale Cancer Center

New Haven, Connecticut 06520-8028

United States

Emory Winship

Atlanta, Georgia 30322

United States

John Theurer Cancer Center-Hackensack

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute

New Brunswick, New Jersey 08901

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Ohio State University

Columbus, Ohio 43201

United States

Providence Cancer Institute

Portland, Oregon 97213

United States

Prisma Health Cancer Institute

Greenville, South Carolina 29605

United States

NEXT Dallas

Dallas, Texas 75039

United States

START Dallas- Fort Worth

Dallas, Texas 76104

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Houston

Houston, Texas 77054

United States

START- San Antonio

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington 98195

United States