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BI 4060107 for Cancer

Not yet recruiting at 5 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: AIMEDBIO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.

Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.

Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that cannot be removed by surgery and who have tried all other available treatments without success. Participants must have no remaining standard treatment options.

Inclusion Criteria

Signed and dated written main informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
I am at least 18 years old and legally able to give consent.
I have no standard treatment options left for my condition.
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Exclusion Criteria

Current enrolment in another investigational device or drug trial
I understand there may be other reasons I cannot join this study.
I have not had any experimental cancer treatments in the past month.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • BI 4060107

Trial Overview

The study tests different doses of a new medicine called BI 4060107 to find the highest dose people can safely tolerate. Participants are grouped by dose level, starting low and increasing if tolerated. The drug is being given to humans for the first time.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Cohort 5: BI 4060107 dose level 5Experimental Treatment1 Intervention
Group II: Cohort 4: BI 4060107 dose level 4Experimental Treatment1 Intervention
Group III: Cohort 3: BI 4060107 dose level 3Experimental Treatment1 Intervention
Group IV: Cohort 2: BI 4060107 dose level 2Experimental Treatment1 Intervention
Group V: Cohort 1: BI 4060107 dose level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AIMEDBIO

Lead Sponsor

Boehringer Ingelheim

Industry Sponsor

Trials
2,566
Recruited
16,150,000+

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