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RecruitingLast updated: 15 February 2024

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

Clinical summary

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).

Conditions

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

BGB-3111-11417-101

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

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

Eligibility

Inclusion

  • Confirmed diagnosis of one of the following:

NHL Cohorts:

  1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
  2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
  3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
  4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1

    CLL/SLL Cohorts:

  5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history

    MCL cohorts:

  6. WHO-defined MCL I. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigatorr

WM cohorts:

g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)

  • Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:

    1. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
    2. DLBCL, FL, MZL, SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ function
  • Adequate pancreatic function indicated by:

    1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)
    2. Serum lipase ≤ 1.5 x ULN

Exclusion

  • Known central nervous system involvement by lymphoma/leukemia
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
  • Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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