Weekly BI 836880 in Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 836880

• Registration Number: NCT02689505
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-24
• Study Start: 2016-04-04
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2025-09
• Results First Submitted: 2025-09-12
• Results First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Results First Posted: 2025-10-01
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40 mg BI 836880	BI 836880	40 mg BI 836880
120 mg BI 836880	BI 836880	120 mg BI 836880
150 mg BI 836880	BI 836880	150 mg BI 836880
180 mg BI 836880	BI 836880	180 mg BI 836880
240 mg BI 836880	BI 836880	240 mg BI 836880

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period).	Determination of the maximum tolerated dose (MTD) in participants with advanced solid tumors. MTD was defined as the highest dose with less than 25% risk of true DLT rate being above 33% in the MTD evaluation period, and could be considered reached if the probability that the true DLT rate was in the target interval (16% to 33%) was sufficiently large during the MTD evaluation period. The MTD evaluation period was defined as 3 weeks after first administration of treatment.
Number of Participants With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period	First treatment cycle, 3 weeks from first administration of trial treatment (MTD evaluation period).	The following drug-related adverse events qualified as DLTs: Common Terminology Criteria for Adverse Events (CTCAE) grade 4 neutropenia \>7 days or complicated by infection; grade \>3 febrile neutropenia; grade = 4 thrombocytopenia; grade \> 3 thrombocytopenia with bleeding; grade \> 3 proteinuria \> 3 non haematological toxicity except: Vomiting or diarrhea responding to supporting treatment, fatigue lasting for less than 4 days, transient grade 3 infusion reaction, any laboratory abnormality, which was considered not clinically relevant by the investigator or resolved spontaneously or could be resolved with appropriate treatment. Hypertension: increase of diastolic blood pressure (BP) by 15 mmHg, which could not be controlled by hypertensive medication and requires a dose reduction of BI 836880 for further treatment course. All related AE leading to an interruption of BI 836880 for more than 14 days until recovery to baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Drug-related Adverse Events (AEs) Leading to Dose Reduction or Discontinuation During the Treatment Period	From first trial drug administration until 42 (Residual Effect Period) days after the last trial drug administration, up to 566 days.	Number of Participants with drug-related adverse Events (AEs) leading to dose reduction or discontinuation during the treatment period.

Trial Locations

Locations (2)

CTR Georges-François Leclerc; 🇫🇷 Dijon, France

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain