Phase 1
N=24
Weekly BI 836880 in Patients With Advanced Solid Tumors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02689505 ↗Enrolled (actual)
24
Serious AEs
50.0%
Results posted
Oct 2025
Primary outcome: Primary: Maximum Tolerated Dose (MTD) — 180 Milligram (mg)
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
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) |
180 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period |
0; 1; 0; 1; 2; 4 | — |
| SECONDARY Number of Participants With Drug-related Adverse Events (AEs) Leading to Dose Reduction or Discontinuation During the Treatment Period |
0; 3; 0; 1; 2; 6 | — |
Summary
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously once a week. The eligible patient population will be patients with advanced solid tumors.
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety data will be evaluated as secondary objectives.
Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid tumors.
Dose escalation will be guided by a Bayesian logistic regression model with over dose control (EWOC) using at least 2 patients per dose cohorts.
Safety criteria will be followed, including adverse events according to Common Terminology Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination, vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).
Eligibility Criteria
Inclusion criteria
1 Age >=18 years 2. Histologically 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. patients 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 1.5 109/L
- Platelet count > 100x109/ L.
- Haemoglobin > 10 g/dl (without transfusion within previous week) 5. Signed and dated written informed consent. 6. Life expectancy >= 3 months in the opinion of the investigator 7. Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE grade1, except for alopecia (any grade), sensory peripheral neuropathy CTCAE grade 470 ms). QTcF will be calculated by Investigator as the mean of the 3 ECGs taken at screening.
- Significant cardiovascular/ cerebrovascular disease (i.e uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > New York heart association ( NYHA II). Uncontrolled hypertension defined as: blood pressure in tested and relaxed condition >= 140 mmHg, systolic or > 90 mmHg diastolic (with or without medication), measured according to Section 5.3.2 and Appendix 10.2.
- 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). No vitamin K antagonist and other anticoagulation allowed; low-molecular-weight heparin (LMWH) allowed only for prevention not for curative treatment.
- Use of alcohol or drug incompatible with patient participation in the study in the investigator opinion
- Patient unable or unwilling to comply with protocol
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Previous enrolment in this trial
Data sourced from ClinicalTrials.gov (NCT02689505). 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.