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NCT02674152

Dose Finding Study of BI 836880 in Patients With Solid Tumors

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

Phase 1 trial testing BI 836880 in Neoplasms in 29 participants. Completed in 4 November 2020.

Timeline
5 January 2016
Primary endpoint
12 September 2018
4 November 2020

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment29
Start date5 January 2016
Primary completion12 September 2018
Estimated completion4 November 2020
Sites3 locations across France, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 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) Primary · Up to 3 weeks after the first administration of trial medication.

Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 0.33 during the MTD evaluation period, defined as 3 weeks after first administration of trial medication (i.e. cycle 1). Patients who did not complete the MTD evaluation period for reasons other than DLT were excluded from the analysis of the primary endpoint.

GroupValue95% CI
BI 836880 - All Dose Groups720
Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period Primary · Up to 3 weeks after the first administration of trial medication.

DTLs are defined as followed: * Drug-related Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non-haematological toxicity * CTCAE Grade 4 neutropenia lasting \>7 days or complicated by infection (please note that in case of grade 4 neutropenia a more frequent follow up of patient was necessary * Febrile neutropenia of CTCAE Grade ≥3 * CTCAE Grade 4 thrombocytopenia or CTCAE Grade ≥3 thrombocytopenia with bleeding * Treatment delay for \>2 weeks due to unresolved drug-related AEs, which started within 3 weeks after the first treatment * Hypertension: increase of diastolic blood

GroupValue95% CI
40 mg BI 8368800
120 mg BI 8368800
360 mg BI 8368800
720 mg BI 8368800
1000 mg BI 8368801
Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period Secondary · From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days.

Number of patients with drug-related adverse events leading to dose reduction or discontinuation during treatment period.

GroupValue95% CI
40 mg BI 8368800
120 mg BI 8368800
360 mg BI 8368800
720 mg BI 8368801
1000 mg BI 8368801
Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose Secondary · 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1.

Area under the serum concentration-time curve over the time interval from 0 extrapolated to infinity (AUC0-tz) after the first dose.

GroupValue95% CI
40 mg BI 8368802180± 152
120 mg BI 8368804100± 38.7
360 mg BI 83688015000± 71.1
720 mg BI 83688032900± 28.1
1000 mg BI 83688040000± 66.6
Terminal Half-life (t_1/2) of BI 836880 Secondary · 5 minutes before start of BI 836880 infusion and immediately after end of infusion (i.e. 1.5 hours (h) after start of infusion) and 2h, 3h, 5h, 8h, 24h, 72h, 168h, 336h and 504h after start of BI 826880 infusion in cycle 1.

Terminal half-life (t\_1/2) of BI 836880.

GroupValue95% CI
40 mg BI 836880241± 16.3
120 mg BI 836880210± 5.07
360 mg BI 836880265± 7.42
720 mg BI 836880289± 19.1
1000 mg BI 836880279± 8.96

Adverse events — posted to ClinicalTrials.gov

Time frame: From first drug infusion until 42 days (residual effect period) after last drug infusion, up to 828 days. For all-cause mortality: From signing informed consent, until end of trial, up to 1546 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

40 mg BI 836880
Serious: 1/3 (33%)
Deaths: 2/3
120 mg BI 836880
Serious: 2/2 (100%)
Deaths: 1/2
360 mg BI 836880
Serious: 1/2 (50%)
Deaths: 0/2
720 mg BI 836880
Serious: 6/17 (35%)
Deaths: 4/17
1000 mg BI 836880
Serious: 5/5 (100%)
Deaths: 2/5
Total BI 836880
Serious: 15/29 (52%)
Deaths: 9/29

Serious adverse events (37 terms)

ReactionSystem40 mg BI 836880120 mg BI 836880360 mg BI 836880720 mg BI 8368801000 mg BI 836880Total BI 836880
DiarrhoeaGastrointestinal disorders——————
InfectionInfections and infestations——————
Pleural effusionRespiratory, thoracic and mediastinal disorders——————
Pulmonary embolismRespiratory, thoracic and mediastinal disorders——————
AnaemiaBlood and lymphatic system disorders——————
NeutropeniaBlood and lymphatic system disorders——————
MyocarditisCardiac disorders——————
Abdominal painGastrointestinal disorders——————
ConstipationGastrointestinal disorders——————
Gastric haemorrhageGastrointestinal disorders——————
GastritisGastrointestinal disorders——————
IleusGastrointestinal disorders——————
Mechanical ileusGastrointestinal disorders——————
NauseaGastrointestinal disorders——————
SubileusGastrointestinal disorders——————
VomitingGastrointestinal disorders——————
DeathGeneral disorders——————
Impaired healingGeneral disorders——————
PainGeneral disorders——————
Bile duct stoneHepatobiliary disorders——————
CholelithiasisHepatobiliary disorders——————
Hepatic failureHepatobiliary disorders——————
Hepatic painHepatobiliary disorders——————
HepatomegalyHepatobiliary disorders——————
Device related infectionInfections and infestations——————
Other adverse events (130 terms — click to expand)

ReactionSystem40 mg BI 836880120 mg BI 836880360 mg BI 836880720 mg BI 8368801000 mg BI 836880Total BI 836880
HypertensionVascular disorders——————
AstheniaGeneral disorders——————
NauseaGastrointestinal disorders——————
VomitingGastrointestinal disorders——————
Aspartate aminotransferase increasedInvestigations——————
AnaemiaBlood and lymphatic system disorders——————
ConstipationGastrointestinal disorders——————
DiarrhoeaGastrointestinal disorders——————
Abdominal painGastrointestinal disorders——————
Oedema peripheralGeneral disorders——————
Urinary tract infectionInfections and infestations——————
ArthralgiaMusculoskeletal and connective tissue disorders——————
DyspnoeaRespiratory, thoracic and mediastinal disorders——————
Infusion related reactionInjury, poisoning and procedural complications——————
Alanine aminotransferase increasedInvestigations——————
Blood bilirubin increasedInvestigations——————
LymphopeniaBlood and lymphatic system disorders——————
Abdominal pain upperGastrointestinal disorders——————
NasopharyngitisInfections and infestations——————
Back painMusculoskeletal and connective tissue disorders——————
HypothyroidismEndocrine disorders——————
HaemorrhoidsGastrointestinal disorders——————
Chest painGeneral disorders——————
PyrexiaGeneral disorders——————
HypersensitivityImmune system disorders——————
Blood alkaline phosphatase increasedInvestigations——————
ProteinuriaRenal and urinary disorders——————
CoughRespiratory, thoracic and mediastinal disorders——————
ThrombocytopeniaBlood and lymphatic system disorders——————
VertigoEar and labyrinth disorders——————
GastritisGastrointestinal disorders——————
Face oedemaGeneral disorders——————
PainGeneral disorders——————
InfectionInfections and infestations——————
Respiratory tract infectionInfections and infestations——————
FallInjury, poisoning and procedural complications——————
Blood lactate dehydrogenase increasedInvestigations——————
Weight decreasedInvestigations——————
Decreased appetiteMetabolism and nutrition disorders——————
HyperkalaemiaMetabolism and nutrition disorders——————

Most-reported serious reactions: Diarrhoea, Infection, Pleural effusion, Pulmonary embolism, Anaemia, Neutropenia, Myocarditis, Abdominal pain.

Data from ClinicalTrials.gov NCT02674152 adverse events section.

Sponsor's own description

This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion

Publications & conference data

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

  1. Discovery of nanobodies: a comprehensive review of their applications and potential over the past five years.
    Alexander E, Leong KW. · · 2024 · cited 83× · PMID 39455963 · DOI 10.1186/s12951-024-02900-y
  2. Expanding the Boundaries of Biotherapeutics with Bispecific Antibodies.
    Husain B, Ellerman D. · · 2018 · cited 83× · PMID 30132211 · DOI 10.1007/s40259-018-0299-9
  3. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
    Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
  4. Research Progress and Applications of Multivalent, Multispecific and Modified Nanobodies for Disease Treatment.
    Wang J, Kang G, Yuan H, Cao X, et al · · 2021 · cited 51× · PMID 35116045 · DOI 10.3389/fimmu.2021.838082
  5. Ang2 inhibitors and Tie2 activators: potential therapeutics in perioperative treatment of early stage cancer.
    Khan KA, Wu FT, Cruz-Munoz W, Kerbel RS. · · 2021 · cited 36× · PMID 34125494 · DOI 10.15252/emmm.201708253
  6. Disrupting cancer angiogenesis and immune checkpoint networks for improved tumor immunity.
    Anderson TS, Wooster AL, Piersall SL, Okpalanwaka IF, et al · · 2022 · cited 23× · PMID 35149179 · DOI 10.1016/j.semcancer.2022.02.009
  7. Applications and challenges in designing VHH-based bispecific antibodies: leveraging machine learning solutions.
    Mullin M, McClory J, Haynes W, Grace J, et al · · 2024 · cited 20× · PMID 38666503 · DOI 10.1080/19420862.2024.2341443
  8. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors.
    Le Tourneau C, Becker H, Claus R, Elez E, et al · · 2022 · cited 13× · PMID 36108560 · DOI 10.1016/j.esmoop.2022.100576

Verify or expand the search:

Other trials of BI 836880

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