This study is open to adults with small cell lung cancer and other neuroendocrine tumours 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 that people can tolerate when taken together with another medicine called ezabenlimab. Obrixtamig and ezabenlimab may help the immune system fight cancer. Participants get obrixtamig and ezabenlimab as infusions into a vein. 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 every week. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Obrixtamig
Ezabenlimab
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Hôpital Louis Pradel
Bron, France
CTR François Baclesse
Caen, France
INS Claudius Regaud IUCT-Oncopole
Toulouse, France
Technische Universität Dresden
Dresden, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period
Time frame: up to 19 months
Occurrence of DLTs during the on-treatment period
Time frame: up to 19 months
Objective response, defined as best overall response of complete response (CR) or partial response (PR)
Objective response, defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined by the investigator's assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in patients with measurable disease from date of first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent
Time frame: up to 19 months
Cmax (maximum measured concentration of obrixtamig)
Time frame: up to 19 months
Cmax (maximum measured concentration of ezabenlimab)
Time frame: up to 19 months
AUCτ (area under the concentration-time curve of obrixtamig over a uniform dosing interval τ)
Time frame: up to 19 months
AUCτ (area under the concentration-time curve of ezabenlimab) over a uniform dosing interval τ)
Time frame: up to 19 months
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