Clinical trial • Phase I • Oncology
obrixtamig (BI 764532) for Small cell lung cancer | Neuroendocrine tumour (DLL3-positive)
Phase I trial of obrixtamig (BI 764532) for Small cell lung cancer | Neuroendocrine tumour (DLL3-positive). 235 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small cell lung cancer | Neuroendocrine tumour (DLL3-positive)
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 04-09-2024
Trial design
Phase I trial across 7 sites in Germany, Spain.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 235
Eligibility
Recruits 235 Vulnerable population not selected; no special consent/assent handling mentioned..
- Vulnerable Population
- Vulnerable population not selected; no special consent/assent handling mentioned.
Recruitment
- Planned Sample Size
- 235
- Recruitment Window Months
- 79
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 235
Germany
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 620
- Number Of Sites
- 3
- Number Of Participants
- 110
Sites
- Site Name
- Technische Universitaet Dresden
- Department Name
- Early Clinical Trial Unit, Universitätsklinikum Carl Gustav Carus Dresden
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Contact Person Name
- Cyrus Sayehli
- Contact Person Email
- sayehli_c@ukw.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für Innere Medizin
- Contact Person Name
- Jürgen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
Spain
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 10-05-2026
- Processing Time Days
- 626
- Number Of Sites
- 4
- Number Of Participants
- 125
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Edurne Arriola Aperribay
- Contact Person Email
- EArriola@parcdesalutmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Miguel Fernández de Sanmamed
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncología Médica
- Contact Person Name
- Enriqueta Felip
- Contact Person Email
- efelip@vhio.net
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Industry
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- obrixtamig (BI 764532)
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)