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NCT02145741

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

Completed Phase 1 Results posted Last updated 19 June 2025
What this trial tests

Phase 1 trial testing 750 milligram Xentuzumab in Neoplasms in 21 participants. Completed in 14 July 2023.

Timeline
11 June 2014
Primary endpoint
1 July 2015
14 July 2023

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designparallel
Maskingnone
Primary purposetreatment
Enrollment21
Start date11 June 2014
Primary completion1 July 2015
Estimated completion14 July 2023
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

20 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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 g

GroupValue95% CI
Xentuzumab (BI 836845)NA

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

750 Milligram Xentuzumab (BI 836845)
Serious: 0/6 (0%)
Deaths: 0/6
1000 Milligram Xentuzumab (BI 836845)
Serious: 3/9 (33%)
Deaths: 0/9
1400 Milligram Xentuzumab (BI 836845)
Serious: 0/6 (0%)
Deaths: 0/6

Serious adverse events (8 terms)

ReactionSystem750 Milligram Xentuzumab (…1000 Milligram Xentuzumab …1400 Milligram Xentuzumab …
Gastrointestinal haemorrhageGastrointestinal disorders———
VertigoEar and labyrinth disorders———
Abdominal painGastrointestinal disorders———
NauseaGastrointestinal disorders———
SepsisInfections and infestations———
Urinary tract infectionInfections and infestations———
Decreased appetiteMetabolism and nutrition disorders———
Pathological fractureMusculoskeletal and connective tissue disorders———
Other adverse events (69 terms — click to expand)

ReactionSystem750 Milligram Xentuzumab (…1000 Milligram Xentuzumab …1400 Milligram Xentuzumab …
DiarrhoeaGastrointestinal disorders———
NauseaGastrointestinal disorders———
FatigueGeneral disorders———
PyrexiaGeneral disorders———
Influenza like illnessGeneral disorders———
Muscle spasmsMusculoskeletal and connective tissue disorders———
NeutropeniaBlood and lymphatic system disorders———
Blood creatine phosphokinase increasedInvestigations———
White blood cell count decreasedInvestigations———
Decreased appetiteMetabolism and nutrition disorders———
HyperglycaemiaMetabolism and nutrition disorders———
Tumour painNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
DizzinessNervous system disorders———
Dental cariesGastrointestinal disorders———
HaemorrhoidsGastrointestinal disorders———
StomatitisGastrointestinal disorders———
ToothacheGastrointestinal disorders———
VomitingGastrointestinal disorders———
Hepatic function abnormalHepatobiliary disorders———
DermatitisSkin and subcutaneous tissue disorders———
RashSkin and subcutaneous tissue disorders———
AnaemiaBlood and lymphatic system disorders———
HypothyroidismEndocrine disorders———
General physical health deteriorationGeneral disorders———
MalaiseGeneral disorders———
PainGeneral disorders———
BronchitisInfections and infestations———
Compression fractureInjury, poisoning and procedural complications———
Alanine aminotransferase increasedInvestigations———
Aspartate aminotransferase increasedInvestigations———
C-reactive protein increasedInvestigations———
Neutrophil count decreasedInvestigations———
HypokalaemiaMetabolism and nutrition disorders———
Back painMusculoskeletal and connective tissue disorders———
Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
InsomniaPsychiatric disorders———
ProteinuriaRenal and urinary disorders———
BronchostenosisRespiratory, thoracic and mediastinal disorders———
CoughRespiratory, thoracic and mediastinal disorders———
Eustachian tube patulousEar and labyrinth disorders———

Most-reported serious reactions: Gastrointestinal haemorrhage, Vertigo, Abdominal pain, Nausea, Sepsis, Urinary tract infection, Decreased appetite, Pathological fracture.

Data from ClinicalTrials.gov NCT02145741 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Insulin-like growth factor receptor signaling in tumorigenesis and drug resistance: a challenge for cancer therapy.
    Hua H, Kong Q, Yin J, Zhang J, et al · · 2020 · cited 172× · PMID 32493414 · DOI 10.1186/s13045-020-00904-3
  2. Present Advances and Future Perspectives of Molecular Targeted Therapy for Osteosarcoma.
    Shaikh AB, Li F, Li M, He B, et al · · 2016 · cited 89× · PMID 27058531 · DOI 10.3390/ijms17040506
  3. Obesity and endocrine-related cancer: The important role of IGF-1.
    Zhong W, Wang X, Wang Y, Sun G, et al · · 2023 · cited 44× · PMID 36755926 · DOI 10.3389/fendo.2023.1093257
  4. IGF2 Mediates Resistance to Isoform-Selective-Inhibitors of the PI3K in HPV Positive Head and Neck Cancer.
    Badarni M, Prasad M, Golden A, Bhattacharya B, et al · · 2021 · cited 10× · PMID 34067117 · DOI 10.3390/cancers13092250
  5. A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors.
    Doi T, Kuboki Y, Naito Y, Ishida M, et al · · 2022 · cited 4× · PMID 34870878 · DOI 10.1111/cas.15231

Verify or expand the search:

Other recruiting trials for Neoplasms

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Other Boehringer Ingelheim trials

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