RecruitingPhase 1NCT07021066

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Advanced or Metastatic Solid Tumors

Sponsor

SystImmune Inc.

Enrollment

160 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer Esophageal Adenocarcinoma Gastric Adenocarcinoma Other Solid Tumors Advanced Pancreatic Ductal Adenocarcinoma

Summary

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called BL-M05D1 (an antibody-drug conjugate targeting a protein called CLDN18.2) in people with advanced solid tumors such as stomach cancer or gastroesophageal junction cancer that has progressed despite prior treatment. **You may be eligible if...** - You are 18 or older with a life expectancy of at least 3 months - You have advanced or metastatic solid tumor(s) that are known to potentially express CLDN18.2 (most commonly stomach or gastroesophageal junction cancer) - Your cancer has progressed on at least one prior treatment and no standard options remain - Your general health and organ function meet study requirements (ECOG adequate function) **You may NOT be eligible if...** - You have uncontrolled brain metastases or active serious infections - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have autoimmune conditions requiring ongoing treatment 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-M05D1

BL-M05D1 will be administered on D1 every 3 weeks.

Locations(17)

Mayo Clinic Cancer Center- Phoenix

Phoenix, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

University of Colorado Health

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute - Oncology Partners

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

NEXT Oncology- Austin

Austin, Texas, United States

NEXT Oncology- Dallas

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

NEXT Oncology San Antonio

San Antonio, Texas, United States

START Center for Care Center- San Antonio

San Antonio, Texas, United States

Baylor Scott and White Medical Center- Temple Clinic

Temple, Texas, United States

View Full Details on ClinicalTrials.gov

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

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NCT07021066

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