NeoplasmsPhase 1NCT02145741

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

A Phase 1 study testing 750 milligram Xentuzumab, 1000 milligram Xentuzumab and 1400 milligram Xentuzumab in people with Neoplasms, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Neoplasms
What is being tested?: 750 milligram Xentuzumab, 1000 milligram Xentuzumab and 1400 milligram Xentuzumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteJapan
Study dates: 11 Jun 2014to 14 Jul 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet all of the following inclusion criteria by the judgment of investigator are eligible to receive the study treatment:
Patients with cytologically or histologically confirmed solid tumours that are refractory to standard therapy, for whom no standard therapy of proven efficacy exists, or who are not amenable to establish treatment options
Age >=20 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Who cannot join

Patients who apply any of the following exclusion criteria by the judgment of investigator are not eligible to receive the study treatment:
Active infectious disease to be incompatible with the study treatment
Patients who do not have sufficient major organ function and meet any of the following test results at screening period
Cardiac left ventricular function with resting ejection fraction <=50% as determined by echocardiography (ECHO) or multiple-gated acquisition scan (MUGA)
Absolute neutrophil count <1500/µL
Platelets <100 000/µL

Show all 19Show fewer

Total bilirubin >1.5 × the upper limit of normal (ULN)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 × ULN (in case of known liver metastases, AST and/or ALT >5 × ULN)
Creatinine >1.5 × ULN
Haemoglobin <9 g/dL
HbA1c >=8% and fasting glucose >8.9 mmol/L (>160 mg/dL)
Serious illness or concomitant non-oncological disease including severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the patient during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results considered by the investigator to be incompatible with the study treatment
History of thrombosis (except tumour invading great vessels) within 1 year before start of study treatment or if concurrent anticoagulation required
Patients not recovered from any therapy-related toxicities from previous chemotherapies, hormonal therapies, immunotherapies, molecular-targeted therapies, or radiotherapies to Common Terminology Criteria for Adverse Events (CTCAE) grade <=1
Patients who have not recovered from any previous surgery and major surgery within the last 4 weeks before start of study treatment
Patients with untreated or symptomatic brain metastases.
Patients who have been treated with any of the following within 4 weeks before start of study treatment: chemotherapies, immunotherapies, radiotherapies (within 2 weeks before start of study treatment for local palliative radiotherapies for the treatment of brain metastasis or extremities), biological therapies, molecular-targeted therapies, hormonal therapies for breast cancer within 2 weeks before start of study treatment, or treatment with other investigational drugs.
Patients who have used any investigational drug within 4 weeks before start of study treatment or who have planned concomitantly use with the trial.
Patients unable to comply with the clinical trial protocol (CTP)

Trial locations and contacts

1 site in 1 country.

Japan1 site

National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577

Other trials in Japan

About this study

Official title: An Open-label Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Conditions: Neoplasms
Being tested: 750 milligram Xentuzumab, 1000 milligram Xentuzumab, 1400 milligram Xentuzumab
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

750 milligram XentuzumabDrug
Also called BI 836845
750 milligram Xentuzumab 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 XentuzumabDrug
Also called BI 836845
1000 milligram Xentuzumab 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 XentuzumabDrug
Also called BI 836845
1400 milligram Xentuzumab 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.

Study groups in NCT02145741
Study group	Role	What they receive
750 milligram Xentuzumab	Experimental	750 milligram Xentuzumab 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. Receives: Drug: 750 milligram Xentuzumab
1000 milligram Xentuzumab	Experimental	1000 milligram Xentuzumab 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. Receives: Drug: 1000 milligram Xentuzumab
1400 milligram Xentuzumab	Experimental	1400 milligram Xentuzumab 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. Receives: Drug: 1400 milligram Xentuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 201414 Jul 2023

First posted23 May 2014 (estimated)
Study start11 Jun 2014
Primary completion1 Jul 2015
Study completion14 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02145741
Sponsor's protocol ID: 1280.15
Status last verified: Jun 2025
First submitted: 21 May 2014
Last updated: 19 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: 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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Publications

Doi T, Kuboki Y, Naito Y, Ishida M, Tanaka T, Takeuchi Y. A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors. Cancer Sci. 2022 Mar;113(3):1010-1017. doi: 10.1111/cas.15231. Epub 2022 Jan 13.
PubMed 34870878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase I Dose Escalation Trial of Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT02145741
Acronym / sponsor ID: 1280.15
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Jun 2014 (actual)
Primary completion: 1 Jul 2015 (actual)
Study completion: 14 Jul 2023 (actual)
First posted: 23 May 2014 (estimated)
Results: Posted 19 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
750 milligram Xentuzumab	Experimental	Drug: 750 milligram Xentuzumab750 milligram Xentuzumab 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	Experimental	Drug: 1000 milligram Xentuzumab1000 milligram Xentuzumab 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	Experimental	Drug: 1400 milligram Xentuzumab1400 milligram Xentuzumab 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.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients who meet all of the following inclusion criteria by the judgment of investigator are eligible to receive the study treatment:
Patients with cytologically or histologically confirmed solid tumours that are refractory to standard therapy, for whom no standard therapy of proven efficacy exists, or who are not amenable to establish treatment options
Age >=20 years old
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Key exclusion criteria (19 listed)

Patients who apply any of the following exclusion criteria by the judgment of investigator are not eligible to receive the study treatment:
Active infectious disease to be incompatible with the study treatment
Patients who do not have sufficient major organ function and meet any of the following test results at screening period
Serious illness or concomitant non-oncological disease including severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the patient during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results considered by the investigator to be incompatible with the study treatment
History of thrombosis (except tumour invading great vessels) within 1 year before start of study treatment or if concurrent anticoagulation required

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
750 milligram XentuzumabAlso: BI 836845750 milligram Xentuzumab 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.	Drug	750 milligram Xentuzumab
1000 milligram XentuzumabAlso: BI 8368451000 milligram Xentuzumab 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.	Drug	1000 milligram Xentuzumab
1400 milligram XentuzumabAlso: BI 8368451400 milligram Xentuzumab 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.	Drug	1400 milligram Xentuzumab

Primary outcome

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)
Time frame: During the first cycle of treatment, up to 21 days of treatment.
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.

Results and safety

Results posted to the registry on 19 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
750 Milligram Xentuzumab (BI 836845)	6	0
1000 Milligram Xentuzumab (BI 836845)	9	3
1400 Milligram Xentuzumab (BI 836845)	6	0

Primary outcome: 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)

Time frame: During the first cycle of treatment, up to 21 days of treatment.. Number. Unit: Milligram

Measure	Xentuzumab (BI 836845) n = 12
Value	NA

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
750 Milligram Xentuzumab (BI 836845)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
1000 Milligram Xentuzumab (BI 836845)	3 of 9 (33.3%)	9 of 9 (100%)	0 of 9
1400 Milligram Xentuzumab (BI 836845)	0 of 6 (0%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34870878Doi T, Kuboki Y, Naito Y, Ishida M, Tanaka T, Takeuchi Y. A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors. Cancer Sci. 2022 Mar;113(3):1010-1017. doi: 10.1111/cas.15231. Epub 2022 Jan 13.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 750 milligram Xentuzumab, 1000 milligram Xentuzumab and 1400 milligram Xentuzumab in people with Neoplasms, run by Boehringer Ingelheim at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: During the first cycle of treatment, up to 21 days of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.