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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Obrixtamig - parenteral 1
Obrixtamig - parenteral 2
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
...and 2 more locations
Arm 1 and Arm 2: Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.
Time frame: up to 36 months
Arm 1 and Arm 2: Number of patients with DLTs in the MTD evaluation period
Time frame: up to 36 months
Arm 1 and Arm 2: Maximum measured concentration (Cmax) of obrixtamig
Time frame: up to 36 months
Arm 1 and Arm 2: Area under the concentration-time curve (AUCτ) of the analyte over a uniform dosing interval τ
Time frame: up to 36 months
Arm 1 and Arm 2: Objective response based on RECIST 1.1 criteria in patients with measurable disease
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease
Time frame: up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.