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CompletedNCT01317420Updated Jul 11, 2025Results posted

Trial to Determine MTD of BI 836845 Administered Intravenously Once Every Three Weeks in Patients With Advanced Solid Tumours and Later a Weekly Dosing Schedule in Selected Tumour Types

A Phase 1 interventional study of BI 836845 in Neoplasms, sponsored by Boehringer Ingelheim. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is a phase I, open-label, dose escalation trial to determine the maximum tolerated dose (MTD) of a new drug BI 836845 which blocks the insulin growth factor (IGF) pathway believed to be involved in cancer growth. BI 836845 will be administered for the very first time into cancer patients.

The study will also look at the overall safety of the drug, and examine the drug levels in the body at specific timepoints during the trial (pharmacokinetic profile); the effect the drug may have on tumours will also be examined (pharmacodynamics).

02

Conditions studied

  • Neoplasms

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 64 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female patients with cytologically or histologically confirmed solid tumours that are refractory to standard therapy or that have no standard therapy.
  2. Patients should have evaluable disease, or at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1
  3. Age, equal, or more than, 18 years old.
  4. Life expectancy of at least 3 months.
  5. Written informed consent that is consistent with ICH-GCP guidelines.
  6. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2.
  7. Patients must have recovered from any previous surgery and no major surgery within the last 28 days prior to start of trial medication.
  8. Cardiac left ventricular function with resting ejection fraction >50% as determined by Echocardiography (ECHO) or Multiple Gated Acquisition scan (MUGA).
  9. Absolute neutrophil count equal, or more than, 1,500/µl.
  10. Platelets equal, or more than, 100,000/µl.
  11. Total bilirubin equal, or less than 1.5 x institution upper limit of normal.
  12. Aspartate Amino Transferase (AST) (Serum glutamic oxaloacetic transaminase (SGOT)) / Alanine Amino Transferase (ALT) (Serum glutamic pyruvic transaminase (SGPT )) equal, or less than, 2.5 x upper limit of normal (in case of known liver metastases AST and/or ALT, equal, or less than, 5 x upper limit of normal).
  13. Creatinine equal, or less than, 1.5 x institution upper limit of normal.
  14. Haemoglobin equal, or more than, 9g/dL.
  15. Haemoglobin A1c less than 8% and fasting glucose, equal, or less than, 8.9 mmol/L (= 160 mg/dL).
  16. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment.
  17. Patients entering part II of the study should have cytologically or histologically confirmed disease from the Ewing's family of tumours/PNET (cohort 1), or solid tumours suitable for biopsy (cohort 2), that are refractory to standard therapy or that have no standard therapy.
  18. Patients eligible to undergo biopsy should have normal coagulation parameters (INR and PTT within normal ranges) and platelet count (equal, or more than, 100,000/µl) prior to biopsy tissue collection.

Exclusion criteria

Exclusion criteria:

  1. Active infectious disease.
  2. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
  3. History of thrombosis within 1 year of study or if concurrent anticoagulation required.
  4. Patients not recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, molecular targeted, or radiotherapies to at least Common Terminology Criteria for Adverse Events (CTCAE) equal, or less than, Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
  5. Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least 4 weeks before starting trial medication, no history of cerebral oedema or bleeding in the past 4 weeks before starting trial medication and must be on a stable or reducing dose of dexamethasone. Anti-epileptic therapy will be allowed if the patient is stable on antiepileptic treatment for 4 weeks, or more, without adjustments before starting trial medication.
  6. Patients who have been treated with any of the following within 4 weeks of starting trial medication: chemotherapy, immunotherapy, radiotherapy, biological therapies (including trastuzumab), molecular targeted, hormone therapy for breast cancer within 2 weeks of starting trial medication (excluding Luteinizing-hormone-releasing hormone (LHRH) agonists in prostate cancer, or bisphosphonates), or treatment with other investigational drugs.
  7. Use of any investigational drug within 4 weeks before start of therapy or concomitantly with this trial.
  8. Patients unable to comply with the protocol.
  9. Active alcohol abuse or active drug abuse (at the discretion of the investigator).
  10. Patients with unstable arrhythmias or unstable angina or severe obstructive pulmonary disease within the last year.
  11. For patients entering part II of the study, prior use of any insulin growth factor (IGF) inhibitor.
  12. Patients with a history of diabetes mellitus.
  13. Pregnancy or breast feeding.
  14. Patients that are to undergo biopsy should not have a history of a hereditary bleeding disorder as judged by the investigator.
  15. Patients that are to undergo biopsy should pause acetylsalicylic acid treatment for at least 7 days prior to biopsy tissue collection.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    BI 836845 10 mg

    Patients received 10 milligram (mg) of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 20 mg

    Patients received 20 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 40 mg

    Patients received 40 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 80 mg

    Patients received 80 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 160 mg

    Patients received 160 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 320 mg

    Patients received 320 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 640 mg

    Patients received 640 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 1280 mg

    Patients received 1280 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 1800 mg

    Patients received 1800 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 2400 mg

    Patients received 2400 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    BI 836845 3600 mg

    Patients received 3600 mg of BI 836845 (concentrate for solution for infusion) given intravenously for 1 hour on Day 1 of each 3-weekly course of treatment until disease progression or undue toxicities in the dose escalation part of the study

    Drug: BI 836845

  • Experimental
    Ewings sarcoma

    Patients with Ewing's family of tumours (EFT) or primitive neuroectodermal tumour (PNET) receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.

    Drug: BI 836845

  • Experimental
    Biopsiable tumours

    Patients with all solid tumour types who had tumours suitable for biopsy receiving relevant biological dose (RBD) of BI 836845 1000 mg, administered in each course of 21 days by a 1-hour infusion at the start of each week in expansion part of the study.

    Drug: BI 836845

Interventions

  • DrugBI 836845

    Intravenous infusion

    Also known as: Xentuzumab

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) or Relevant Biological Dose (RBD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase

    To determine the MTD or relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase. The MTD was defined as the highest dose level of BI 836845 below the maximum dose administered at which no more than 1 out of 6 patients experienced a drug-related DLT during the first course of treatment. Starting dose of 10 mg BI 836845, administered once every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg, 640 mg, 1280 mg, 1800 mg, 2400 mg, and 3600 mg. In the absence of the MTD, the RBD, where a plateau in total Insulin-like growth factor 1 (IGF-1) level and total neutralisation of IGF activity is predicted, is reported.

    Time frame: During the first course of treatment, up to 21 days

  2. Percentage of Patients With Dose Limiting Toxicities (DLTs) During the First Treatment Course of the Dose Escalation Phase

    DLTs defined as drug related: CTCAE Grade 4 neutropenia lasting ≥7 days; febrile neutropenia and/or documented infection with Absolute Neutrophil Count \<1.0x109/L; Grade 4 thrombocytopaenia or Grade 3 associated with bleeding needing platelet transfusion; Grade ≥3 increased hepatic enzymes; Grade 3 or 4 non-haematologic toxicity with exceptions; Grade ≥2 infusion reaction despite adequate pre-medication; Grade ≥2 nausea and/or vomiting persisting for ≥7 days despite antiemetic treatment; Grade ≥3 skin toxicity despite adequate supportive care measures for up to 2 weeks if it does not reach an improvement to grade ≤2; Grade ≥3 hyperglycaemia resistant to treatment with anti-diabetic agents; any electrolyte grade 3 AE refractory to optimal correction therapy; no recovery from a non-DLT grade \>2 toxicity to grade 1 within 14 days of administered dose; sustained fatigue/asthenia grade 3 for \>96 h associated with deterioration of Performance score (Eastern Cooperative Oncology Group).

    Time frame: During the first course of treatment, up to 21 days

Secondary outcomes

  1. Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1

    Best overall response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) based on RECIST criteria version 1.1: CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 millimeters \[mm\] short axis). PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study. PD: At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm; Appearance of 1 or more new lesions; Unequivocal progression of existing non-target lesions.

    Time frame: First treatment administration, up to 246 days.

  2. Objective Tumour Response

    Objective response was defined as best overall response of CR or PR (with no confirmation required).

    Time frame: First treatment administration, up to 246 days.

  3. Duration of Objective Response

    Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).

    Time frame: First treatment administration, up to 246 days.

  4. Disease Control

    Disease control was defined as best overall response of CR, PR (confirmation was not required for CR or PR) or confirmed SD (i.e. lasting for at least 24 weeks).

    Time frame: First treatment administration, up to 246 days.

  5. Progression-free Survival (PFS)

    PFS was evaluated in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier.

    Time frame: First treatment administration until tumour progression or death, up to 162 days.

  6. Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Cmax)

    Maximum measured concentration of the analyte in plasma (Cmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

    Time frame: Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.

  7. Area Under the Plasma Concentration-time Curve (AUC)

    Area under the plasma concentration-time curve (AUC) of the analyte (BI 836845); AUC(0-504) in part 1 using 3- weekly dosing and AUC(0-168) in part 2 using weekly dosing.

    Time frame: Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.

  8. Time to Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Tmax)

    Time to maximum measured concentration of the analyte in plasma (tmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

    Time frame: Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.

  9. Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

    Percentage of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, 14 June 2010 are presented. When no CTCAE grading was available for a specific event, the intensity of the AE was judged based on the following: * Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which were easily tolerated. * Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity. * Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities. * Grade 4 - Life-threatening or disabling AE. * Grade 5 - Death related to AE.

    Time frame: From first drug administration, until 21 days after last drug administration, up to 253 days.

07

Results

Posted Jul 11, 2025

Participant flow

Open label, uncontrolled, dose escalation, 3+3 design, and multicenter study in two parts. Part 1: dose escalation in patients with advanced solid tumours to determine the MTD or RBD. Part 2: expansion part at the RBD in patients with selected tumour types more likely to benefit from BI 836845 (Cohort 1- Ewing's family of tumours or PNET; Cohort 2 - biopsiable solid tumours) in order to investigate safety and PK/pharmacodynamics.

Participant flow — Overall Study
MilestoneBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
Started333333333331120
Completed0000000000000
Not completed333333333331120
Withdrew: Progressive disease according to recist233333333231116
Withdrew: Other adverse event1000000000002
Withdrew: Non-compliant with protocol0000000000001
Withdrew: Refused to cont. taking trial medication0000000000001
Withdrew: Reason other than those specified0000000001000

Outcome measures

PrimaryMaximum Tolerated Dose (MTD) or Relevant Biological Dose (RBD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase

To determine the MTD or relevant biological dose (RBD) of BI 836845 during the first treatment course of the dose escalation phase. The MTD was defined as the highest dose level of BI 836845 below the maximum dose administered at which no more than 1 out of 6 patients experienced a drug-related DLT during the first course of treatment. Starting dose of 10 mg BI 836845, administered once every 3 weeks. Dose levels evaluated were: 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, 320 mg, 640 mg, 1280 mg, 1800 mg, 2400 mg, and 3600 mg. In the absence of the MTD, the RBD, where a plateau in total Insulin-like growth factor 1 (IGF-1) level and total neutralisation of IGF activity is predicted, is reported.

Time frame:
During the first course of treatment, up to 21 days
Reported as:
Number · mg
Maximum Tolerated Dose (MTD) or Relevant Biological Dose (RBD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase
mgBI 836845
Maximum Tolerated Dose (MTD) or Relevant Biological Dose (RBD) of BI 836845 During the First Treatment Course of the Dose Escalation Phase1000
PrimaryPercentage of Patients With Dose Limiting Toxicities (DLTs) During the First Treatment Course of the Dose Escalation Phase

DLTs defined as drug related: CTCAE Grade 4 neutropenia lasting ≥7 days; febrile neutropenia and/or documented infection with Absolute Neutrophil Count \<1.0x109/L; Grade 4 thrombocytopaenia or Grade 3 associated with bleeding needing platelet transfusion; Grade ≥3 increased hepatic enzymes; Grade 3 or 4 non-haematologic toxicity with exceptions; Grade ≥2 infusion reaction despite adequate pre-medication; Grade ≥2 nausea and/or vomiting persisting for ≥7 days despite antiemetic treatment; Grade ≥3 skin toxicity despite adequate supportive care measures for up to 2 weeks if it does not reach an improvement to grade ≤2; Grade ≥3 hyperglycaemia resistant to treatment with anti-diabetic agents; any electrolyte grade 3 AE refractory to optimal correction therapy; no recovery from a non-DLT grade \>2 toxicity to grade 1 within 14 days of administered dose; sustained fatigue/asthenia grade 3 for \>96 h associated with deterioration of Performance score (Eastern Cooperative Oncology Group).

Time frame:
During the first course of treatment, up to 21 days
Reported as:
Number · percentage of participants
Percentage of Patients With Dose Limiting Toxicities (DLTs) During the First Treatment Course of the Dose Escalation Phase
percentage of participantsBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mg
Percentage of Patients With Dose Limiting Toxicities (DLTs) During the First Treatment Course of the Dose Escalation Phase00000000000
SecondaryBest Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1

Best overall response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) based on RECIST criteria version 1.1: CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (\<10 millimeters \[mm\] short axis). PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study. PD: At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm; Appearance of 1 or more new lesions; Unequivocal progression of existing non-target lesions.

Time frame:
First treatment administration, up to 246 days.
Reported as:
Number · Percentage of participants
Best Overall Response Based on Response Evaluation Criteria In Solid Tumours (RECIST) Criteria Version 1.1
Percentage of participantsBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
CR0000000000000
PR0000000000000
SD33330003333336767333645
PD67331001001006767333333675525
Not evaluable0330000033000930
SecondaryObjective Tumour Response

Objective response was defined as best overall response of CR or PR (with no confirmation required).

Time frame:
First treatment administration, up to 246 days.
Reported as:
Number · Percentage of participants
Objective Tumour Response
Percentage of participantsBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
Objective Tumour Response0000000000000
SecondaryDuration of Objective Response

Duration of objective response (days), defined as time from first objective response to the time to progression or death and was only calculated for patients with an objective response (with no confirmation required).

Time frame:
First treatment administration, up to 246 days.

No measurements were reported for this outcome.

SecondaryDisease Control

Disease control was defined as best overall response of CR, PR (confirmation was not required for CR or PR) or confirmed SD (i.e. lasting for at least 24 weeks).

Time frame:
First treatment administration, up to 246 days.
Reported as:
Number · Percentage of participants
Disease Control
Percentage of participantsBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
Disease Control000003300033000
SecondaryProgression-free Survival (PFS)

PFS was evaluated in expansion phase of the study. PFS was defined as the time from first treatment administration until tumour progression according to RECIST 1.1 or death from any cause, whichever occurred earlier.

Time frame:
First treatment administration until tumour progression or death, up to 162 days.
Reported as:
Median · days
Progression-free Survival (PFS)
daysEwings SarcomaBiopsiable Tumours
Progression-free Survival (PFS)37.0 (30.0 to 86.0)79.0 (36.0 to 85.0)
SecondaryMaximum Measured Concentration of the Analyte (BI 836845) in Plasma (Cmax)

Maximum measured concentration of the analyte in plasma (Cmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

Time frame:
Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.
Reported as:
Geometric mean · microgram/milliliter (µg/mL)
Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Cmax)
microgram/milliliter (µg/mL)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgCourse 1Course 2Course 3
Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Cmax)2.45 ± 10.65.24 ± 46.110.7 ± 65.817.7 ± 17.966.2 ± 113196 ± 163146 ± 47.8421 ± 30.8727 ± 101554 ± 11.51080 ± 10.3295 ± 19.9399 ± 26.7419 ± 26.5
SecondaryArea Under the Plasma Concentration-time Curve (AUC)

Area under the plasma concentration-time curve (AUC) of the analyte (BI 836845); AUC(0-504) in part 1 using 3- weekly dosing and AUC(0-168) in part 2 using weekly dosing.

Time frame:
Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.
Reported as:
Geometric mean · microgram*hour/milliliter (µg*h/mL)
Area Under the Plasma Concentration-time Curve (AUC)
microgram*hour/milliliter (µg*h/mL)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgCourse 1Course 2Course 3
Area Under the Plasma Concentration-time Curve (AUC)363 ± 1.79724 ± 26.8993 ± 30.91910 ± 50.55270 ± 21.612100 ± 27.617300 ± 61.734600 ± 68.242100 ± 6.5578500 ± 6.3287800 ± 24.924100 ± 22.137300 ± 33.336900 ± 41.6
SecondaryTime to Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Tmax)

Time to maximum measured concentration of the analyte in plasma (tmax) in the first cycle of treatment (dose escalation phase, part 1) and in the first 3 cycles of treatment (dose expansion phase, part 2).

Time frame:
Part 1: 5 minutes before and 0.5, 1, 2, 4, 7, 24, 72, 168 and 336 h after infusion for Course 1. Part 2: 5 minutes before and 1, 2, 4, 7, 24, 168, 169, 336, 337 h after infusion for Course 1, 2 and 3.
Reported as:
Median · hours
Time to Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Tmax)
hoursBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgCourse 1Course 2Course 3
Time to Maximum Measured Concentration of the Analyte (BI 836845) in Plasma (Tmax)2.2 ± 10.62.0 ± 46.11.0 ± 65.82.1 ± 17.91.0 ± 1132.0 ± 1632.0 ± 47.82.3 ± 30.82.0 ± 1014.0 ± 11.51.8 ± 10.32.5 ± 19.93.0 ± 26.71.0 ± 26.5
SecondaryIncidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Percentage of patients with adverse events (AEs) according to the grading as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, 14 June 2010 are presented. When no CTCAE grading was available for a specific event, the intensity of the AE was judged based on the following: * Grade 1 - Mild AE; awareness of sign(s) or symptom(s) which were easily tolerated. * Grade 2 - Moderate AE; enough discomfort to cause interference with usual activity. * Grade 3 - Severe AE; incapacitating or causing inability to work or to perform usual activities. * Grade 4 - Life-threatening or disabling AE. * Grade 5 - Death related to AE.

Time frame:
From first drug administration, until 21 days after last drug administration, up to 253 days.
Reported as:
Number · Percentage of participants
Incidence and Intensity of Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Percentage of participantsBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
Grade 166.70.033.333.333.30.00.033.333.333.30.018.225.0
Grade 20.033.333.30.033.30.066.733.30.033.366.745.545.0
Grade 30.066.733.366.733.3100.00.033.366.733.333.327.330.0
Grade 433.30.00.00.00.00.033.30.00.00.00.09.10.0
Grade 50.00.00.00.00.00.00.00.00.00.00.00.00.0

Adverse events

Collected over From first drug administration, until 21 days after last drug administration, up to 253 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BI 836845 10 mg—1/3 (33.3%)3/3 (100%)
BI 836845 20 mg—1/3 (33.3%)3/3 (100%)
BI 836845 40 mg—0/3 (0%)3/3 (100%)
BI 836845 80 mg—1/3 (33.3%)3/3 (100%)
BI 836845 160 mg—0/3 (0%)3/3 (100%)
BI 836845 320 mg—3/3 (100%)3/3 (100%)
BI 836845 640 mg—1/3 (33.3%)3/3 (100%)
BI 836845 1280 mg—1/3 (33.3%)2/3 (66.7%)
BI 836845 1800 mg—1/3 (33.3%)2/3 (66.7%)
BI 836845 2400 mg—0/3 (0%)3/3 (100%)
BI 836845 3600 mg—0/3 (0%)3/3 (100%)
Ewings Sarcoma—5/11 (45.5%)11/11 (100%)
Biopsiable Tumours—10/20 (50%)20/20 (100%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
Eye swellingEye disorders0/30/30/30/30/30/30/30/31/30/30/30/110/20
Abdominal pain upperGastrointestinal disorders0/30/30/30/30/30/31/30/30/30/30/30/110/20
NauseaGastrointestinal disorders0/30/30/30/30/30/30/31/30/30/30/30/111/20
Oesophageal haemorrhageGastrointestinal disorders0/30/30/30/30/30/30/31/30/30/30/30/110/20
VomitingGastrointestinal disorders0/30/30/30/30/30/30/31/30/30/30/30/112/20
Hepatic function abnormalHepatobiliary disorders0/30/30/30/30/30/30/31/30/30/30/30/110/20
Device related infectionInfections and infestations0/30/30/30/30/31/30/30/30/30/30/30/110/20
Escherichia urinary tract infectionInfections and infestations0/30/30/30/30/31/30/30/30/30/30/30/110/20
Gastroenteritis norovirusInfections and infestations0/30/30/30/30/30/30/30/31/30/30/30/110/20
PneumoniaInfections and infestations1/30/30/30/30/30/30/30/30/30/30/30/110/20
Most frequent other events
Showing 10 of 106
Most frequent other events
EventBI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable Tumours
DiarrhoeaGastrointestinal disorders0/31/30/31/32/31/31/30/30/33/32/31/114/20
Decreased appetiteMetabolism and nutrition disorders1/31/32/31/30/31/30/30/31/33/32/31/117/20
FatigueGeneral disorders2/31/31/32/30/30/31/32/31/30/32/31/1114/20
AnaemiaBlood and lymphatic system disorders1/30/31/31/30/30/30/31/30/30/32/32/115/20
Abdominal painGastrointestinal disorders0/30/30/30/31/31/32/31/31/31/30/30/113/20
Dry mouthGastrointestinal disorders0/30/30/32/31/30/30/30/30/30/31/30/113/20
NauseaGastrointestinal disorders2/30/30/32/30/31/32/31/30/31/30/33/118/20
VomitingGastrointestinal disorders1/30/32/31/30/30/32/31/31/30/30/33/114/20
HypokalaemiaMetabolism and nutrition disorders0/30/30/30/30/30/31/32/31/30/32/32/111/20
Back painMusculoskeletal and connective tissue disorders0/31/32/31/30/30/30/30/30/31/30/31/114/20

Baseline characteristics

Treated set: All enrolled patients who gave informed consent and who were documented to have taken at least one dose of investigational treatment. The treated set was used for all planned analyses.

Age, Continuous
Age, Continuous(years)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable TumoursTotal
Mean60.7 ± 16.355.7 ± 20.656.0 ± 11.139.0 ± 17.463.0 ± 14.443.0 ± 17.351.0 ± 20.046.3 ± 14.664.0 ± 1.066.3 ± 12.563.7 ± 8.129.7 ± 9.260.3 ± 10.752.5 ± 16.8
Sex: Female, Male
Sex: Female, Male(Participants)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable TumoursTotal
Female012121120123824
Male3212122132181240
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable TumoursTotal
Hispanic or Latino00000000000000
Not Hispanic or Latino33333333333112064
Unknown or Not Reported00000000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BI 836845 10 mgBI 836845 20 mgBI 836845 40 mgBI 836845 80 mgBI 836845 160 mgBI 836845 320 mgBI 836845 640 mgBI 836845 1280 mgBI 836845 1800 mgBI 836845 2400 mgBI 836845 3600 mgEwings SarcomaBiopsiable TumoursTotal
American Indian or Alaska Native00000000000000
Asian01000001000002
Native Hawaiian or Other Pacific Islander00000000000000
Black or African American00000000000000
White32333332333112062
More than one race00000000000000
Unknown or Not Reported00000000000000
08

Study locations

2 sites
  • St James's University Hospital
    Leeds, LS9 7TF, United Kingdom
  • The Royal Marsden Hospital, Sutton
    Sutton, SM2 5PT, United Kingdom
09

References and documents

Publications

  • de Bono J, Lin CC, Chen LT, Corral J, Michalarea V, Rihawi K, Ong M, Lee JH, Hsu CH, Yang JC, Shiah HS, Yen CJ, Anthoney A, Jove M, Buschke S, Fuertig R, Schmid U, Goeldner RG, Strelkowa N, Huang DC, Bogenrieder T, Twelves C, Cheng AL. Two first-in-human studies of xentuzumab, a humanised insulin-like growth factor (IGF)-neutralising antibody, in patients with advanced solid tumours. Br J Cancer. 2020 Apr;122(9):1324-1332. doi: 10.1038/s41416-020-0774-1. Epub 2020 Mar 12. PubMed 32161368 ↗

Related links

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01317420
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Mar 17, 2011
Start date
Apr 13, 2011
Primary completion
Feb 15, 2016
Completion
Feb 15, 2016
Results posted
Jul 11, 2025
Last update
Jul 11, 2025

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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