Trial Outcomes & Findings for Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours (NCT NCT02145741)

Last Updated: 2025-06-19

Results Overview

MTD of xentuzumab in Japanese patients with advanced solid tumours, as identified by the number of patients with DLTs. The MTD of xentuzumab was defined as the highest dose tested with DLT occurring in not more than 1 out of 6 evaluable patients. DLTs were defined as: Haematological toxicities: Common Terminology Criteria for Adverse Events (CTCAE) grade (g) 4 neutropenia ≥7 days (d), select cases of Febrile neutropenia, Infections or CTCAE g4 thrombocytopenia or CTCAE g3 thrombocytopenia. Non-haematological toxicities: CTCAE grade 3 or 4 non-haematologic toxicity, with exceptions CTCAE grade≥2 infusion reaction or nausea and/or vomiting with exceptions CTCAE grade ≥3 skin toxicity, hyperglycaemia, any electrolyte adverse events (AE), fatigue or asthenia with exceptions No recovery from a non-DLT CTCAE g≥3 toxicity to g≤1 within 14 d of administered dose Other drug-related AEs (CTCAE g2), might qualify as a DLT, which will be determined on a case by case bases.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

During the first cycle of treatment, up to 21 days of treatment.

Results posted on

2025-06-19

Participant Flow

This was an open-label study, with a dose escalation cohort according to a 3+3 design followed by an expansion cohort.

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	750 Milligram Xentuzumab (BI 836845) 750 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1000 Milligram Xentuzumab (BI 836845) 1000 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1400 Milligram Xentuzumab (BI 836845) 1400 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
Overall Study STARTED	6	9	6
Overall Study Maximum Tolerated Dose (MTD) Set	3	3	6
Overall Study COMPLETED	0	3	0
Overall Study NOT COMPLETED	6	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	750 Milligram Xentuzumab (BI 836845) 750 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1000 Milligram Xentuzumab (BI 836845) 1000 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1400 Milligram Xentuzumab (BI 836845) 1400 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
Overall Study Progressive disease	3	6	6
Overall Study quality issue with the administered drug	3	0	0

Baseline Characteristics

Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	750 Milligram Xentuzumab (BI 836845) n=6 Participants 750 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1000 Milligram Xentuzumab (BI 836845) n=9 Participants 1000 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1400 Milligram Xentuzumab (BI 836845) n=6 Participants 1400 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	Total n=21 Participants Total of all reporting groups
Age, Continuous	60.33 years STANDARD_DEVIATION 10.82 • n=93 Participants	52.00 years STANDARD_DEVIATION 16.58 • n=4 Participants	64.67 years STANDARD_DEVIATION 9.16 • n=27 Participants	58.00 years STANDARD_DEVIATION 21.91 • n=483 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	8 Participants n=483 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	13 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	9 Participants n=4 Participants	6 Participants n=27 Participants	21 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	6 Participants n=93 Participants	9 Participants n=4 Participants	6 Participants n=27 Participants	21 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: During the first cycle of treatment, up to 21 days of treatment.

Population: The Maximum tolerated dose (MTD) set was defined as the set of patients that were fully evaluable for the MTD in the first treatment cycle.

Outcome measures

Outcome measures
Measure	Xentuzumab (BI 836845) n=12 Participants Comprises all dose cohorts (750, 1000 and 1400 milligram) in the dose escalation cohort. Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
Maximum Tolerated Dose (MTD) of Xentuzumab in Japanese Patients With Advanced Solid Tumours, as Identified by the Number of Patients With Dose-limiting Toxicities (DLTs)	NA Milligram There were no dose-limiting toxicities experienced by any patient during the MTD evaluation period, thus MTD was not reached.

Adverse Events

750 Milligram Xentuzumab (BI 836845)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

1000 Milligram Xentuzumab (BI 836845)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

1400 Milligram Xentuzumab (BI 836845)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	750 Milligram Xentuzumab (BI 836845) n=6 participants at risk 750 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1000 Milligram Xentuzumab (BI 836845) n=9 participants at risk 1000 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.	1400 Milligram Xentuzumab (BI 836845) n=6 participants at risk 1400 milligram Xentuzumab (BI 836845) given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Infections and infestations Sepsis	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Infections and infestations Urinary tract infection	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	11.1% 1/9 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.	0.00% 0/6 • Adverse events collection: From first day of treatment until the last day of treatment + the residual effect period (42 days), up to 1499 days. All-cause mortality: From start of study till the end of study, up to 1527 days. Treated set - This patient set included all patients who were documented to have received and taken at least 1 dose of trial medication during the treatment cycles since Day 1.

Other adverse events

Additional Information

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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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