RecruitingPhase 1NCT06293898

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Sponsor

SystImmune Inc.

Enrollment

280 participants

Start Date

Feb 9, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Esophageal Cancer Gastric Cancer Gastroesophageal-junction Cancer Biliary Tract Cancer Ovarian Cancer Cervical Cancer Endometrial Cancer Urothelial Carcinoma Lung Cancer

Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BL-M07D1 — an antibody-drug conjugate (a targeted therapy that delivers chemotherapy directly to cancer cells) — in people with advanced solid tumors that produce too much of a protein called HER2. HER2-expressing cancers include certain uterine, cervical, ovarian, bladder, and biliary tract cancers. **You may be eligible if...** - You are 18 or older with locally advanced or metastatic HER2-expressing cancer (confirmed by lab testing) - Your cancer has not responded to at least 2 standard treatment lines - Your cancer is in one of the specific tumor types the study is investigating (e.g., endometrial, cervical, ovarian, bladder, biliary tract cancers) - You are in reasonably good health with a life expectancy over 3 months **You may NOT be eligible if...** - Your tumor does not express HER2 - You have not received prior standard treatments - You have significant heart, liver, or lung problems 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-M07D1

Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M17D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1

Locations(17)

University of Alabama Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

Cedars Sinai

Los Angeles, California, United States

Scripps Health

San Diego, California, United States

University of Miami

Miami, Florida, United States

Sarah Cannon Research institute - Lake Nona Florida

Orlando, Florida, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Chicago Medicine

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institiute

Detroit, Michigan, United States

NYU Langone Hospital - Long Island Investigational Pharmacy

Mineola, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Oncology Consultants

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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

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NCT06293898

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