Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04958239
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2021-07-01
Brief Title:
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer Solid Tumors and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab BI 754091 in Patients With Advanced Solid Cancers and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable Recurrent Head and Neck Squamous Cell Carcinoma HNSCC
Status:
RECRUITING
Status Verified Date:
2024-09
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 advanced cancer solid tumors and people with advanced head and neck cancer The study has 2 parts The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer
In Part 1 each participant is put into 1 of 2 groups Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks In Part 2 participants are also divided into 2 groups 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab Participants receive the study treatment as infusions into a vein
BI 765179 ezabenlimab and pembrolizumab are antibodies that may help the immune system fight cancer In this study BI 765179 is given to people for the first time
Participants can stay in the study up to 3 years Part 1 or 2 years Part 2 if they benefit from treatment and can tolerate it The doctors regularly check the participants health and note any health problems that could have been caused by the study treatment
In Part 1 each participant is put into 1 of 2 groups Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks In Part 2 participants are also divided into 2 groups 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab Participants receive the study treatment as infusions into a vein
BI 765179 ezabenlimab and pembrolizumab are antibodies that may help the immune system fight cancer In this study BI 765179 is given to people for the first time
Participants can stay in the study up to 3 years Part 1 or 2 years Part 2 if they benefit from treatment and can tolerate it The doctors regularly check the participants health and note any health problems that could have been caused by the study treatment
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 |
|---|---|---|---|
| 2021-000234-34 | EUDRACT_NUMBER | None | None |