A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers
CompletedPhase 1Results postedLast updated 19 February 2025
What this trial tests
Phase 1 trial testing BI 905711 in Gastrointestinal Cancer, Metastatic in 13 participants. Completed in 14 November 2023.
18 and older, any sex, with Gastrointestinal Cancer, Metastatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Determination of the Maximum Tolerated Dose (MTD) of BI 905711Primary· From cycle 1 Day 1 until the day before cycle 3 Day 1 (2 14-day treatment cycles), or end of the residual effect period (REP) (30 days + 5 days) in case of discontinuation before start of cycle 3, up to 35 days.
Maximum tolerated dose (MTD) was defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being equal or above 33% during the MTD evaluation period.
The MTD was to be considered reached if one of the following criteria was fulfilled: the posterior probability of the true DLT rate in the target interval (0.16, 0.33) of the MTD was above 0.5, or at least 12 patients had been treated in Phase Ia, of which at least 6 at the MTD.
Group
Value
95% CI
BI 905711 + FOLFIRI + Bevacizumab
NA
Number of Patients With Dose Limiting Toxicity (DLT) During MTD EvaluationPrimary· From cycle 1 Day 1 until the day before cycle 3 Day 1 (2 14-day treatment cycles), or end of the REP (30 days + 5 days) in case of discontinuation before start of cycle 3, up to 35 days.
Number of patients with dose limiting toxicity (DLT) during MTD evaluation is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
0
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
2
Confirmed Objective Response (OR)Primary· From the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, up to 54 weeks.
Confirmed objective response (OR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI in patients with measurable disease, defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death or last evaluable tumor assessment before start of subsequent anti-cancer therapy.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
0
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
0
FOLFIRI + Bevacizumab
0
Maximum Measured Plasma Concentration of BI 905711 During the First Cycle (Cmax)Secondary· At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ia is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
6100
± 36.6
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
11500
± 23.9
Maximum Measured Plasma Concentration of BI 905711 After Multiple Cycles (Cmax)Secondary· Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Maximum measured plasma concentration of BI 905711 after multiple cycles (Cmax) in phase Ia is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
6660
± 25.4
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
9280
± 23.8
Area Under the Concentration-time Curve in Plasma of BI 905711 During the First Cycle (AUC0-336)Secondary· At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion in cycle 1.
Area under the concentration-time curve in plasma of BI 905711 during the first cycle (AUC0-336) in phase Ia is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
372000
± 53.4
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
702000
± 49.4
Area Under the Concentration Time-curve in Plasma of BI 905711 After Multiple Cycles (AUC0-336)Secondary· Cycle 3: At 5 minutes (min) before start of BI 905711 infusion and at 30 min, 7 hours (hrs), 24 hrs, 48 hrs, 168 hrs and 336 hrs after BI 905711 infusion.
Area under the concentration time-curve in plasma of BI 905711 after multiple cycles (AUC0-336) in phase Ia is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
352000
± 73.3
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
565000
± 29.0
Progression Free Survival (PFS)Secondary· From date of start of treatment to the date of disease progression or death, whichever is earlier as assessed by the investigator according to RECIST 1.1., up to 54 weeks.
Progression-Free Survival (PFS) defined from date of start of treatment to the date of disease progression or death, whichever is earlier as assessed by the investigator according to RECIST 1.1 is presented.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
31.00
8.43 – 39.29
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
29.57
11.71 – 33.43
FOLFIRI + Bevacizumab
NA
NA – NA
Maximum Percentage Change From Baseline in the Sum of Longest Target Lesion DiametersSecondary· At baseline and every 8 weeks (± 7 days) until progression or start of further treatment for disease, up to 54 weeks.
Radiological (CT Scan) tumor shrinkage, defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions according to RECIST 1.1. is presented.
Negative values indicate a reduction in the sum of target lesion diameters and positive values indicate an increase. Median change from baseline was calculated for each patient and then summarized over all patients.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
-13.9
-28.3 – 18.6
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
4.5
-21.7 – 6.3
Disease ControlSecondary· From the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy, up to 54 weeks.
Disease control, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting at least 16 weeks according to RECIST 1.1 from the start of treatment until the earliest of PD, death or last evaluable tumor assessment and before start of subsequent anti-cancer therapy.
Group
Value
95% CI
0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab
248.0
120 – 325
1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab
220.5
207 – 234
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 54 weeks..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with chemotherapy and bevacizumab. The purpose of the first part is to find the highest BI 905711 dose participants can tolerate. In the second part, participants with colorectal cancer or pancreatic cancer get BI 905711 combined with chemotherapy. Some participants also get bevacizumab. The second part tests whether BI 905711 makes tumours shrink. Participants get BI 905711, chemotherapy and bevacizumab about every 2 weeks as an infusion into a vein. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check the health of the participants and note any health problems that could have been caused by the study treatment. The doctors also monitor the size of the tumour.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04137289 — A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer
· Phase 1
· completed
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 19 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05087992.