Phase 1
N=29
Dose Finding Study of BI 836880 in Patients With Solid Tumors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02674152 ↗Enrolled (actual)
29
Serious AEs
51.7%
Results posted
Oct 2025
Primary outcome: Primary: Maximum Tolerated Dose (MTD) — 720 Milligram
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 836880 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
720 | — |
| PRIMARY Number of Patients With Dose-limiting Toxicities (DLT) in the Maximum Tolerated Dose (MTD) Period |
0; 0; 0; 0; 1 | — |
| SECONDARY Number of Patients With Drug-related Adverse Events Leading to Dose Reduction or Discontinuation During Treatment Period |
0; 0; 0; 1; 1 | — |
| SECONDARY Area Under the Serum Concentration-time Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-tz) After the First Dose |
2180; 4100; 15000; 32900; 40000 | — |
| SECONDARY Terminal Half-life (t_1/2) of BI 836880 |
241; 210; 265; 289; 279 | — |
Summary
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
Eligibility Criteria
Inclusion criteria
- Age >= 18 years
- Histologically or cytologically confirmed malignancy which is locally advanced or metastatic solid tumor, and either refractory after standard therapy for the disease or for which standard therapy is not reliably effective, e.g. they do not tolerate or have contraindications to otherwise available standard therapy and tumour lesions evaluable for Dynamic contrast-enhanced (DCE)-MRI at MTD.
- ECOG performance status 470 ms). QTcF will be calculated by Investigator as the mean of the 3 ECGs taken at screening.
- Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > NYHA II). Uncontrolled hypertension defined as: blood pressure in rested and relaxed condition >=140 mmHg systolic, or >=90 mmHg diastolic (with or without medication), measured according to protocol.
- History of severe haemorrhagic or thromboembolic event in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis).
- Known inherited predisposition to bleeding or to thrombosis in the opinion of the investigator.
- Patient with brain metastases that are symptomatic and/or require therapy.
- Patients who require full-dose anticoagulation (according to local guidelines).
- Active alcohol or drug abuse in the opinion of the investigator.
- Patients who are under judicial protection and patients who are legally institutionalized.
- Patients unable or unwilling to comply with protocol
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Data sourced from ClinicalTrials.gov (NCT02674152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.