BI 1823911 + BI 1701963 for Cancer

Recruiting at 14 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Anticancer chemotherapy, Anticancer hormonal

Disqualifiers: Cardiovascular abnormalities, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 39 months

30 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop any previous anticancer chemotherapy at least 3 weeks before starting the trial drug, and any anticancer hormonal treatment or immunotherapy at least 2 weeks before. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug BI 1823911 + BI 1701963 for cancer?

The research on BI-847325, a similar drug that targets MEK and Aurora kinases, shows high activity against various cancers, including leukemia, melanoma, and colorectal cancer, suggesting potential effectiveness for BI 1823911 + BI 1701963 in treating cancer. ^{1 2 3 4 5}

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 1823911 alone or in combination with BI 1701963 to determine the maximum tolerated dose and evaluate efficacy

up to 39 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• BI 1701963
• BI 1823911

Trial Overview The 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

Group I: Monotherapy Arm Experimental Treatment 2 Interventions

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

Group II: Combination Therapy Arm Experimental Treatment 2 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).

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Remarkable Response to Olaparib in a Patient with Combined Hepatocellular-Cholangiocarcinoma Harboring a Biallelic BRCA2 Mutation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

High In Vitro and In Vivo Activity of BI-847325, a Dual MEK/Aurora Kinase Inhibitor, in Human Solid and Hematologic Cancer Models. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis on the Prognostic Value of BRCA Mutations, Homologous Recombination Gene Mutations, and Homologous Recombination Deficiencies in Cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

A phase I study of two dosing schedules of oral BI 847325 in patients with advanced solid tumors. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Anti-TGF-β/PD-L1 bispecific antibody promotes T cell infiltration and exhibits enhanced antitumor activity in triple-negative breast cancer. [2023]