Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

Brief summary public domain (ClinicalTrials.gov)

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response (OR) [From the date of treatment start until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 25.0 months.]. Number, percentage of participants (95% Confidence Interval). Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 18.2 (9.76 to 29.61); Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 0.0 (0.00 to 30.85); Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): 45.5 (16.75 to 76.62); Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 18.2 (2.28 to 51.78).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Objective Response (DOR) [From first documented confirmed objective response (OR) until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 23.9 months.]. Median, months (95% Confidence Interval). Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=12): 8.50 (5.40 to 15.60); Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=5): 9.10 (5.40 to NA) [Not evaluable due to low number of participants with the event.]; Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=2): 3.75 (3.00 to NA) [Not evaluable due to low number of participants with the event.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS) [From treatment start until the earliest date of tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Up to 25.0 months.]. Median, months (95% Confidence Interval). Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 4.20 (3.00 to 5.00); Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 1.40 (1.20 to NA) [Upper Limit of the 95% Confidence Interval could not be calculated due to low number of participants with the event.]; Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): 8.00 (3.00 to 14.00); Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 3.10 (1.40 to 5.10).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [From treatment start until death from any cause. Up to 28.1 months.]. Median, months (95% Confidence Interval). Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 10.10 (6.90 to 12.30); Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 4.30 (3.10 to 7.80); Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): NA (6.60 to NA) [Median and Upper Limit of the 95% Confidence Interval could not be calculated due to low number of participants with the event.]; Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 5.10 (2.00 to 11.10).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control (DC) [From the date of treatment start until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 25.0 months.]. Number, percentage of participants (95% Confidence Interval). Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 75.8 (63.64 to 85.46); Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 40.0 (12.16 to 73.76); Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): 90.9 (58.72 to 99.77); Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 54.5 (23.38 to 83.25).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Occurrence of Treatment-emergent Adverse Events (AEs) During the On-treatment Period [From first day of administration of brigimadlin until last administration of brigimadlin plus 30 days of residual effect period (REP), up to 28.4 months.]. Count Of Participants, Participants. Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 65; Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 10; Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): 11; Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 11.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Occurrence of Treatment-emergent AEs Leading to Trial Drug Discontinuation During the On-treatment Period [From first day of administration of brigimadlin until last administration of brigimadlin plus 30 days of residual effect period (REP), up to 28.4 months.]. Count Of Participants, Participants. Brigimadlin 45 mg: Cohort 1 (Biliary Tract Adenocarcinoma) (n=66): 4; Brigimadlin 45 mg: Cohort 2 (Pancreatic Ductal Adenocarcinoma) (n=10): 0; Brigimadlin 45 mg: Cohort 3 (Lung Adenocarcinoma) (n=11): 0; Brigimadlin 45 mg: Cohort 4 (Urothelial Bladder Cancer) (n=11): 1.