CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
BI-1206 single agent dose escalation phase +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02933320
NCT02933320Phase 2Completed
CompareCT.gov

A Cancer Research UK Phase I/IIa Clinical Trial of BI-1206; an Antibody to FcƔRIIB (CD32b), as a Single Agent and in Combination With an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Malignancy

Cancer Research UK·interventional·Posted Oct 14, 2016·Updated Jul 8, 2021

In Brief

A Phase 2 clinical trial evaluating BI-1206 single agent dose escalation phase, Combination of BI-1206 with rituximab escalation phase, and 2 other interventions for B-cell Lymphoma and 2 related conditions. Completed, enrolled 14 participants across 5 sites.

Detailed Summary

The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Lymphoma, Chronic Lymphocytic Leukaemia, Waldenström Macroglobulinemia
CountriesUnited Kingdom
CollaboratorsBioInvent International AB, Bloodwise

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 14, 2016
Enrollment StartOct 27, 2016
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.7 years ago

Interventions

BI-1206 single agent dose escalation phasebiological

BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.

Combination of BI-1206 with rituximab escalation phasebiological

An investigation of combination treatment of BI-1206 with rituximab.

BI-1206 single agent expansion phasebiological

BI-1206 single agent expansion phase at the RP2D.

Combination of BI-1206 with rituximab expansion phasebiological

BI-1206 in combination with rituximab at the RP2D.