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

NCT02145741 | Completed Phase 1 Results

• 1 other identifier: 1280.15
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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 weekly intravenous administration.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (3)

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.

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.

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.

Drug: 1400 milligram Xentuzumab

Interventions

750 milligram Xentuzumab DRUG

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.

Also known as: BI 836845

750 milligram Xentuzumab

1000 milligram Xentuzumab DRUG

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.

Also known as: BI 836845

1000 milligram Xentuzumab

1400 milligram Xentuzumab DRUG

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.

Also known as: BI 836845

1400 milligram Xentuzumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

Related Publications (1)

• 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.

  PMID: 34870878 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Interventions

xentuzumab

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: June 11, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 14, 2023
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)