RecruitingPhase 1NCT05983432

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors

Sponsor

SystImmune Inc.

Enrollment

470 participants

Start Date

Aug 8, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Triple-Negative Breast Cancer Esophageal Cancer Ovarian Cancer Cervical Cancer Endometrial Cancer Lung Cancer Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma Nasopharyngeal Cancer Small Cell Lung Cancer Prostate Adenocarcinoma

Summary

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug combination called BL-B01D1 in people with advanced solid tumors. The drug is designed to deliver chemotherapy directly to cancer cells. The study focuses primarily on non-small cell lung cancer and other tumor types that have not responded to prior treatments. **You may be eligible if:** - You are 18 or older with advanced, incurable cancer that has spread - Your cancer is one of the target types: non-small cell lung cancer, HER2-negative breast cancer, esophageal cancer, small cell lung cancer, or head and neck squamous cell cancer - You have already received appropriate prior therapies for your cancer type - You have a life expectancy of at least 3 months - Your general health is sufficient to tolerate treatment **You may NOT be eligible if:** - You have untreated brain metastases or serious central nervous system disease - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have had serious side effects from prior cancer treatments that haven't resolved 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-B01D1

BL-B01D1 will be administered either on a Day 1 or Day 1 Day 8 dosing regimen

Locations(39)

Beverly Hills Cancer Center

Beverly Hills, California, United States

City of Hope Cancer Center

Duarte, California, United States

Chao Family Comprehensive Cancer Care and Ambulatory Care

Irvine, California, United States

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

University of California Irvine Medical Center

Orange, California, United States

UCLA Santa Monica

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Sara Cannon Research Institute Lake Nona

Orlando, Florida, United States

Hematology - Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center Head Neck Services

New York, New York, United States

PRISMA Health/ITOR

Greenville, South Carolina, United States

Sarah Cannon - Tennessee Oncology

Nashville, Tennessee, United States

Oncology Consultants, P.A.

Houston, Texas, United States

University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

University of Washington Fred Hutchinson

Seattle, Washington, United States

Centre Léon Bérard

Lyon, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

Saint-Herblain, France

Institut Gustave Roussy

Villejuif, France

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Italy

IRCCS Istituto Clinico Humanitas, Cancer Center

Rozzano, Italy

National Cancer Center Hospital

Chūōku, Japan

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu I Sant Pau

Barcelona, Spain

Hospital Beata María Ana

Madrid, Spain

START Madrid / Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

START Madrid / Centro Integral Oncologico Clara Campal

Madrid, Spain

START Rioja

Piqueras, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

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NCT05983432

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