Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324357
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-03-15
Brief Title:
Beamion BCGC-1 A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2 Cancer That Has Spread
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Beamion BCGC-1 A Phase Ib Dose Escalation and Phase II Dose Optimization Randomized Open-label Multicenter Trial of Oral Zongertinib BI 1810631 in Combination With Intravenous Trastuzumab Deruxtecan T-DXd or in Combination With Intravenous Trastuzumab Emtansine T-DM1 for Treatment of Patients With Advanced HER2 Metastatic Breast Cancer mBC and Metastatic Gastric Gastroesophageal Junction or Esophageal Adenocarcinoma mGEAC
Status:
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 aged 18 years and older with different types of HER2 cancer that has spread and cannot be removed by surgery People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2 cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan T-DXd or with trastuzumab emtansine T-DM1 Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink Zongertinib inhibits HER2 HER2 causes cancer cells to grow
The study is split into treatment cycles All study participants are treated with zongertinib in combination with T-DXd or with T-DM1 This study has 2 parts In Part 1 participants receive increasing doses of zongertinib In Part 2 participants are put into different groups by chance Each group receives a different dose of zongertinib Every participant has an equal chance of being in each group
During the study the participants visit the study site regularly In this study researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1 To find this out researchers look at certain severe health problems that a number of participants have The doctors regularly check the size of the tumour with imaging methods CTMRI during the study The doctors also regularly check participants health and take note of any unwanted effects
The study is split into treatment cycles All study participants are treated with zongertinib in combination with T-DXd or with T-DM1 This study has 2 parts In Part 1 participants receive increasing doses of zongertinib In Part 2 participants are put into different groups by chance Each group receives a different dose of zongertinib Every participant has an equal chance of being in each group
During the study the participants visit the study site regularly In this study researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1 To find this out researchers look at certain severe health problems that a number of participants have The doctors regularly check the size of the tumour with imaging methods CTMRI during the study The doctors also regularly check participants health and take note of any unwanted effects
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