Trial Outcomes & Findings for 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 (NCT NCT05087992)

Last Updated: 2025-02-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

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.

Results posted on

2025-02-19

Participant Flow

The main objective of this phase Ia/Ib, open label, multicentre, dose escalation followed by expansion cohorts study was to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE), and to explore the pharmacokinetics, pharmacodynamics, safety and efficacy of BI 905711 in combination with FOLFIRI regimen plus bevacizumab in colorectal adenocarcinoma (CRC) patients.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/squaremeters (m2) over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Overall Study STARTED	9	3	1
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	9	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/squaremeters (m2) over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	2	0
Overall Study clinical disease progression	3	1
Overall Study objective disease progression	4	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=9 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/squaremeters (m2) over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab n=1 Participants Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	Total n=13 Participants Total of all reporting groups
Age, Continuous	54.4 Years STANDARD_DEVIATION 10.7 • n=5 Participants	60.3 Years STANDARD_DEVIATION 11.2 • n=7 Participants	NA Years n=5 Participants	54.6 Years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	3 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Population: Maximum tolerated dose evaluation set (MTDS): This included all patients in the TS who were not replaced for the MTD determination. The MTDS was used for the primary analyses of dose-limiting toxicities (DLTs) and MTD determination.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=12 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Determination of the Maximum Tolerated Dose (MTD) of BI 905711	NA milligram / kilogram (mg/kg) Criteria for reaching MTD were not fulfilled.	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=6 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Number of Patients With Dose Limiting Toxicity (DLT) During MTD Evaluation	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: 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.

Population: Treated set (TS): This included all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS was used for both safety and efficacy analyses.

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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=9 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab n=1 Participants Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Confirmed Objective Response (OR)	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Population: Due to the stopping criteria in the protocol of the clinical development of BI 905711, recruitment in this trial was prematurely discontinued during the Phase Ib expansion phase and no PDAC patients were enrolled.

In safety run-in part of Pancreatic Ductal Adenocarcinoma (PDAC) cohort. Number of PDAC patients with DLTs during the MTD evaluation period assessed in the first 6 patients is presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Population: Pharmacokinetic parameter analysis set (PKS): This included all subjects in the treated set (TS) who provided at least one PK endpoint and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Maximum measured plasma concentration of BI 905711 during the first cycle (Cmax) in phase Ia is presented.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=9 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Maximum Measured Plasma Concentration of BI 905711 During the First Cycle (Cmax)	6100 nanograms / milliliter (ng/ml) Geometric Coefficient of Variation 36.6	11500 nanograms / milliliter (ng/ml) Geometric Coefficient of Variation 23.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=9 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Maximum Measured Plasma Concentration of BI 905711 After Multiple Cycles (Cmax)	6660 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 25.4	9280 nanograms/milliliter (ng/ml) Geometric Coefficient of Variation 23.8	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=8 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Area Under the Concentration-time Curve in Plasma of BI 905711 During the First Cycle (AUC0-336)	372000 hours * nanograms/milliliter (h*ng/ml) Geometric Coefficient of Variation 53.4	702000 hours * nanograms/milliliter (h*ng/ml) Geometric Coefficient of Variation 49.4	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=8 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Area Under the Concentration Time-curve in Plasma of BI 905711 After Multiple Cycles (AUC0-336)	352000 hours * nanograms/milliliter (h*ng/ml) Geometric Coefficient of Variation 73.3	565000 hours * nanograms/milliliter (h*ng/ml) Geometric Coefficient of Variation 29.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=9 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab n=1 Participants Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Progression Free Survival (PFS)	31.00 weeks Interval 8.43 to 39.29	29.57 weeks Interval 11.71 to 33.43	NA weeks Patient did not progress

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=8 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Maximum Percentage Change From Baseline in the Sum of Longest Target Lesion Diameters	-13.9 Percentage change in tumor diameter Interval -28.3 to 18.6	4.5 Percentage change in tumor diameter Interval -21.7 to 6.3	—

SECONDARY outcome

Timeframe: From the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented, up to 54 weeks.

The duration of OR is measured from the time measurement criteria are first met for complete response (CR)/ partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented (taking as reference for PD the smallest measurements recorded on study) according to RECIST 1.1. .

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	BI 905711 + FOLFIRI + Bevacizumab n=6 Participants Comprises all dose cohorts during the dose escalation phase. Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 or 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=2 Participants Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Disease Control	248.0 days Interval 120.0 to 325.0	220.5 days Interval 207.0 to 234.0	—

SECONDARY outcome

Timeframe: 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.

Population: Due to the termination of the clinical development of BI 905711, recruitment in this trial was prematurely discontinued during the Phase Ib expansion phase and no PDAC patients were enrolled.

Other events: 3 other events

Deaths: 2 deaths

FOLFIRI + Bevacizumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.6 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=9 participants at risk Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/squaremeters (m2) over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	1.2 mg/kg BI 905711 + FOLFIRI + Bevacizumab n=3 participants at risk Patients with colorectal adenocarcinoma (CRC) received a single administration of 1.2 mg/kg of BI 905711 intravenously on Day 3 of each 14-day cycle. Patients also received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.	FOLFIRI + Bevacizumab n=1 participants at risk Patients with colorectal adenocarcinoma (CRC) received FOLFIRI (irinotecan: 180 mg/m2 over 1.5 hours (hrs), leucovorin \[or levoleucovorin\]: 400 mg/m2 (in Japan: levoleucovorin: 200 mg/m2) over 2 hrs, fluorouracil: 400 mg/m2 bolus or 2400 mg/m2 46 hrs continuous infusion) in combination with bevacizumab, 5 mg/kg over 30 minutes (min) intravenously on Day 1 of each 14-day cycle.
Blood and lymphatic system disorders Leukopenia	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Blood and lymphatic system disorders Neutropenia	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Blood and lymphatic system disorders Thrombocytopenia	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	33.3% 1/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Gastrointestinal disorders Enterocolitis	0.00% 0/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	33.3% 1/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Gastrointestinal disorders Oesophagitis	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
General disorders Pyrexia	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Hepatobiliary disorders Biliary obstruction	0.00% 0/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	33.3% 1/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	33.3% 1/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Infections and infestations COVID-19	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Infections and infestations Gastroenteritis Escherichia coli	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Infections and infestations Infection	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.
Infections and infestations Oesophageal infection	11.1% 1/9 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/3 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.	0.00% 0/1 • Up to 54 weeks. Treated set (TS): This includes all subjects who were dispensed study medication and were documented to have been treated with at least one dose of BI 905711 or chemotherapy. This TS is used for both safety and efficacy analyses.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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