Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528093
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-human Open Label Phase IaIb MulticenterMultiregional Dose Escalation Study of BI 765883 Administered Intravenously as Monotherapy and in Combination With Gemcitabine and Nab-paclitaxel in Unselected Patients With Metastatic Pancreatic Ductal Adenocarcinoma mPDAC or Patients With PDAC Who Have Relapsed Within 6 Months After Post-surgery Adjuvant Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists
The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer In this study BI 765883 is given to humans for the first time
Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy Participants can stay in the study as long as they benefit from treatment and can tolerate it At study visits doctors collect information on any health problems of the participants and check the severity of participants cancer
The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer In this study BI 765883 is given to humans for the first time
Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy Participants can stay in the study as long as they benefit from treatment and can tolerate it At study visits doctors collect information on any health problems of the participants and check the severity of participants cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None