BI 1823911 + BI 1701963 for Cancer

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is open to adults with different types of advanced or metastatic cancer (including lung cancer, colorectal cancer, pancreatic cancer, and bile duct cancer). This study is for people for whom previous treatment was not successful or no treatment exists. People who have a tumour with a KRAS mutation can participate in the study. A KRAS mutation makes tumours grow faster. BI 1823911 and BI 1701963 are medicines that may turn off KRAS, each in a different way. In this study, BI 1823911 is given to people for the first time. The purpose of this study is to find the highest dose of BI 1823911 that people can tolerate when taken alone and together with BI 1701963. The most suitable dose is used to find out whether BI 1823911 alone and in combination with BI 1701963 can make tumours shrink. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, participants take tablets of BI 1823911 alone or in combination with BI 1701963 once a day. The doctors regularly monitor the size of the tumour. Doctors also regularly record any unwanted effects and check participant's health.

Research Team

Eligibility Criteria

Adults with advanced cancers (like lung, colorectal, pancreatic, bile duct) that have a specific KRAS mutation and haven't responded to previous treatments or lack treatment options. They must be relatively healthy (ECOG status of 0 or 1), have certain normal organ function levels, measurable tumors per RECIST criteria, and acceptable blood counts.

Inclusion Criteria

I have at least one tumor that can be measured and hasn't been radiated.

My cancer has a specific KRAS G12C mutation.

My cancer is advanced and has been confirmed by tests.

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Exclusion Criteria

My heart's pumping ability is below normal.

I haven't taken experimental drugs or targeted therapy within the last 28 days.

I haven't had cancer hormone therapy or immunotherapy in the last 2 weeks.

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Treatment Details

Interventions

BI 1701963 (Other)
BI 1823911 (Other)

Trial OverviewThe trial is testing BI 1823911 alone and combined with BI 1701963 in different doses to find the highest tolerable amount for patients. It aims to see if these drugs can shrink tumors in those with a particular KRAS mutation. Participants will take tablets daily as long as they benefit without severe side effects.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Monotherapy ArmExperimental Treatment2 Interventions

Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).

Group II: Combination Therapy ArmExperimental Treatment2 Interventions

Will be started after confirmation of safety in the Monotherapy Arm. Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).