Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05882058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-05-22
Brief Title:
DAREON-5 A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
DAREON-5 An Open-label Multi-center Phase II Dose Selection Trial of Intravenous BI 764532 a DLL3-targeting T Cell Engager in Patients With RelapsedRefractory Extensive-stage Small Cell Lung Cancer and in Patients With Other RelapsedRefractory Neuroendocrine Carcinomas
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults with small cell lung cancer and other neuroendocrine tumours 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 a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone 2 different doses of BI 764532 are tested in this study Another purpose is to check whether BI 764532 can make tumours shrink BI 764532 is an antibody-like molecule DLL3CD3 bispecific that may help the immune system fight cancer
Participants are put into 2 groups randomly which means by chance One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532 Participants get BI 764532 infusions into a vein when starting treatment If there is benefit for the participants and if they can tolerate it the treatment is given up to the maximum duration of the study During this time participants visit the study site regularly The total number of visits depends on how they respond to and tolerate the treatment The first study visits include an over-night stay to monitor participants safety Doctors record any unwanted effects and regularly check the general health of the participants
The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone 2 different doses of BI 764532 are tested in this study Another purpose is to check whether BI 764532 can make tumours shrink BI 764532 is an antibody-like molecule DLL3CD3 bispecific that may help the immune system fight cancer
Participants are put into 2 groups randomly which means by chance One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532 Participants get BI 764532 infusions into a vein when starting treatment If there is benefit for the participants and if they can tolerate it the treatment is given up to the maximum duration of the study During this time participants visit the study site regularly The total number of visits depends on how they respond to and tolerate the treatment The first study visits include an over-night stay to monitor participants safety Doctors record any unwanted effects and regularly check the general health of the participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504247-13-00 | REGISTRY | None | None |
| U1111-1292-4406 | REGISTRY | UTN WHO registry | None |