RecruitingPhase 1NCT07080242

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

Sponsor

SystImmune Inc.

Enrollment

120 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Metastatic or Locally Advanced Neuroendocrine Cancer Metastatic or Locally Advanced Neuroendocrine Prostate Cancer Metastatic or Locally Advanced Poorly Differentiated Gastroenteropancreatic Neuroendocrine Carcinoma Metastatic or Locally Advanced Merkel Cell Carcinoma Locally Advanced or Metastatic Large Cell Neuroendocrine Carcinoma of the Lung Metastatic or Locally Advanced Extrapulmonary Neuroendocrine Carcinoma Poorly Differentiated and/or High Grade Neuroendocrine Neoplasms With Evidence of DLL3 Expression

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

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BL-M14D1 in people with advanced or metastatic neuroendocrine tumors and cancers — including small cell lung cancer (SCLC), certain types of digestive tract neuroendocrine cancers, Merkel cell carcinoma, and others — that have not responded to standard treatment. BL-M14D1 is a targeted therapy designed to seek out and destroy cancer cells that carry a specific protein called DLL3. **You may be eligible if...** - You are 18 or older and weigh more than 40 kg - You have confirmed advanced neuroendocrine cancer that has progressed after at least one standard treatment - Your tumor has DLL3 expression (for certain study groups) - Your heart, liver, kidneys, and bone marrow are functioning adequately **You may NOT be eligible if...** - You have received prior treatment with a topoisomerase-based antibody-drug therapy - You have had a heart attack, severe heart failure, or serious heart rhythm problems within 6 months - You have active autoimmune disease, active hepatitis B or C, or HIV - You have untreated brain metastases or existing severe nerve damage - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-M14D1

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

Locations(20)

Valkyrie Clinical Trials

Los Angeles, California, United States

UCLA

Los Angeles, California, United States

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

San Francisco, California, United States

University of Colorado - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Emory Winship

Atlanta, Georgia, United States

University of Kentucky - Markey Cancer Center

Lexington, Kentucky, United States

John Theurer Cancer Center-Hackensack

Hackensack, New Jersey, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Providence Cancer Institute

Portland, Oregon, United States

Prisma Health Cancer Institute

Greenville, South Carolina, United States

NEXT Dallas

Dallas, Texas, United States

START Dallas- Fort Worth

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Houston

Houston, Texas, United States

START- San Antonio

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07080242

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