BGB-3111-11417-101 : A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Chronic Lymphocytic Leukaemia,Diffuse Large Cell Lymphoma,Follicular Lymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

This phase I trial is trying to determine the best dosing level of a targeted therapy drug (BGB-11417), and assess its effectiveness both by itself and in combination with another targeted therapy (Zanubrutinib).
 

This trial is treating patients with Mature B-Cell Malignancies (Lymphoma).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1a/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This is a non-randomised trial with two treatment arms, both with a dose finding and dose escalation phase. In the Experimental BGB-11417 Monotherapy Dose Finding (Part 1) Arm, participants with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), marginal zone lymphoma (MZL) or transformed NHL; chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral BGB-11417 until the maximum tolerated dose (MTD) (or maximum ascending dose (MAD)) and recommended phase 2 dose can be determined. In the Experimental BGB-11417 Monotherapy Expansion Arm (Part 2), Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral BGB-11417 at the RP2D dose to further define the safety profile. In the Experimental BGB-11417 + Zanubrutinib combination therapy dose finding (Part 3) Arm, Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral BGB-11417 until RP2D can be determined in combination with zanubrutinib. In the Experimental BGB-11417 + Zanubrutinib Combination Therapy Dose Expansion (Part 4) Arm, Participants with R/R indolent NHL including FL, MZL; aggressive NHL including DLBCL, transformed NHL; CLL/SLL with low tumor burden or low creatine clearance; CLL/SLL with without high tumor burden or low creatine clearance will receive oral BGB-11417 at the RP2D dose to further define the safety profile in combination with zanubrutinib. BGB-11417 will be administered via film-coated tablets once daily at a dose as specified in the treatment arm. Zanubrutinib will be administered 320mg twice-daily as two 80mg capsules (160mg twice a day) or once-daily zanubrutinib should be administered as four 80mg capsules once a day (320mg once a day).

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@monashhealth.org
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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