A Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of Obrixtamig (BI 764532) Combined With Ezabenlimab in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3

Official Summary

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 Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 45 participants

Interventions

• DRUG: Obrixtamig — Obrixtamig
• DRUG: Ezabenlimab — Ezabenlimab

Primary Outcomes

• Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period (up to 19 months)

Secondary Outcomes

• Occurrence of DLTs during the on-treatment period (up to 19 months)
• Objective response, defined as best overall response of complete response (CR) or partial response (PR) (up to 19 months)
• Cmax (maximum measured concentration of obrixtamig) (up to 19 months)
• Cmax (maximum measured concentration of ezabenlimab) (up to 19 months)
• AUCτ (area under the concentration-time curve of obrixtamig over a uniform dosing interval τ) (up to 19 months)

Trial Locations

• 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

More Small Cell Lung Carcinoma (SCLC) Trials

View all Small Cell Lung Carcinoma (SCLC) clinical trials