RecruitingPhase 1NCT04429087

A Study to Test Different Doses of Obrixtamig in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3


Sponsor

Boehringer Ingelheim

Enrollment

300 participants

Start Date

Jul 29, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of obrixtamig and the best treatment schedule that people can tolerate. Obrixtamig is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, obrixtamig is given to people for the first time. Interim clinical data are available for obrixtamig. Participants get obrixtamig either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different doses of an experimental drug called BI 764532 in people with small cell lung cancer or other tumors that have a protein called DLL3 on their surface. **You may be eligible if...** - You have small cell lung cancer or another DLL3-positive tumor - You have tried standard treatments that are no longer working - You are able to carry out daily activities without much difficulty - You are 18 or older **You may NOT be eligible if...** - You have previously been treated with a T-cell engager or cell therapy that targets DLL3 - You have active brain metastases that are not well controlled - You have significant heart, liver, or kidney problems - 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

DRUGObrixtamig - parenteral 1

Obrixtamig - parenteral 1

DRUGObrixtamig - parenteral 2

Obrixtamig - parenteral 2


Locations(12)

Winship Cancer Institute

Atlanta, Georgia, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Universitätsklinikum Köln (AöR)

Cologne, Germany

Technische Universität Dresden

Dresden, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Hospital del Mar

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Clínica Universidad de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT04429087