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Rituximab

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Immunologic Factors

BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).

Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).

Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 chronic lymphocytic leukaemia (CLL) patients and six mantle cell lymphoma (MCL) patients.

Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.

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.

BI-1206 single agent dose escalation phase

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

Combination of BI-1206 with rituximab escalation phase

BI-1206 single agent expansion phase at the RP2D.

BI-1206 single agent expansion phase

BI-1206 in combination with rituximab at the RP2D.

Combination of BI-1206 with rituximab expansion phase

Andrew Davies, Prof

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.

The molecule CD32b is thought to be present on many B-cells including the malignant B-cells in some types of lymphoma and leukaemia. The study drug, BI-1206, is an anti-CD32b monoclonal antibody which attaches to CD32b on the surface of B-cells and is thought to act by recruiting host immune cells toward the tumour leading to cancer cell death as well as enhancing the anti-cancer effect of other anti-CD20 antibodies such as rituximab by stopping them being absorbed by cells.

The study is a first in man clinical trial of the drug called BI-1206 on its own and then also in combination with an anti-CD20 antibody (such as rituximab) which is commonly used to treat lymphoma and some types of leukaemia.

The four main aims of this trial are to find out:

* The maximum dose of BI-1206 that can be given safely to patients (to a maximum dose of 800mg) on it's own and in combination with an anti-CD20 antibody, rituximab.
* More about the potential side effects of BI-1206 and how they can be managed.
* What happens to BI-1206 inside the body.
* The effect of BI-1206 treatment (with or without rituximab) on tumour size and survival.

Approximately 81 patients with relapsed or refractory CD32b positive B-cell lymphoma or leukaemia were planned for the trial. Approximately 34 patients to establish the maximum tolerated doses (MTDs) in Part A and a further 40 to 50 patients recruited to two expansion cohorts; one of BI-1206 alone and one of BI-1206 plus rituximab (Part B). The final number depending on the number of dose escalations required to reach the MTD.

BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia

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

To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients.

Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies.

Maximum observed serum concentration after intravenous BI-1206 administration

Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration.

BI-1206 half-life after intravenous administration

Total body clearance after intravenous BI-1206 administration

Volume of distribution after administration of BI-1206

Number of patients with B-lymphocyte depletion during BI-1206 treatment period.

To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies

To measure the time to disease progression and twelve month survival

BioInvent International AB

Bloodwise

Cancer Research UK

Trial terminated before part B opened. No patients in arm B.

BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy).

BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.

Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase

Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts).

Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.

Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase

Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients.

BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.

Part B: Arm1: BI-1206 Single Agent Expansion Phase

Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients.

Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.

Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

Total

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United Kingdom

Region of Enrollment

The trial was terminated early by the Sponsor based on a strategic decision and not a safety related decision. At the time of trial termination, 14 patients had received BI-1206. No patients received rituximab. As a result of the early termination Part B of the trial did not open.

Regulatory Affairs Manager

All AEs

Related AEs

DLT - ALT

DLT - AST

DLT - infusion related reaction

Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206.

Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody.

0.4 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)

100 mg BI-1206 (Cohort 2) Dose 1

100 mg BI-1206 (Cohort 2) Dose 4

Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort.

Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206

Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206

0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)

10 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)

Measurement of PK Parameter Half-life (T1/2) for BI-1206

10 - 50 mg BI-1206 (Cohort 1 intra patient dose escalation)

Measurement of PK Parameter Total Body Clearance (CL) for BI-1206

Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206

Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA

Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry.

Stable disease

Progressive disease

Not evaluable

Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008).

Spots Global Cancer Trial Database for cd32b

Every month we try and update this database with for cd32b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd32b

Every month we try and update this database with for cd32b cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd32b cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.