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A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Primary Purpose

B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BGB-16673
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
  2. Age ≥ 18 years
  3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL, FL, MCL, CLL/SLL, or WM.
  4. Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks.
  5. For dose-finding and dose-expansion, patients who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
  6. Measurable disease by radiographic assessment or serum IgM level (WM only)
  7. ECOG Performance Status of 0 to 2
  8. Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy; patients with CLL/SLL or MCL enrolling in the expansion cohorts must have been treated with a BTKi in a prior line of therapy.

Exclusion Criteria:

  1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
  2. Requires ongoing systemic treatment for any other malignancy
  3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
  4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether patient had received treatment for central nervous system disease
  5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, or history of or currently suspected Richter's transformation.

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

Sites / Locations

  • University of Alabama At Birmingham HospitalRecruiting
  • Mayo Clinic PhoenixRecruiting
  • University of Arizona Cancer CenterRecruiting
  • University of California San Diego (Ucsd) Moores Cancer CenterRecruiting
  • Valkyrie Clinical TrialsRecruiting
  • UCLA Santa Monica Cancer CareRecruiting
  • Stanford MedicineRecruiting
  • Mayo Clinic JacksonvilleRecruiting
  • Tampa General Hospital Cancer InstituteRecruiting
  • Norton Cancer Institute PavilionRecruiting
  • Mary Bird Perkins Cancer CenterRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Mayo Clinic RochesterRecruiting
  • Nebraska Cancer SpecialistsRecruiting
  • Weill Cornell Medical College Newyork Presbyterian HospitalRecruiting
  • Columbia University Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer Center MskccRecruiting
  • Md Anderson Cancer CenterRecruiting
  • Virginia Commonwealth University Massey Cancer CenterRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Concord Repatriation General HospitalRecruiting
  • St Vincents Hospital MelbourneRecruiting
  • Peter Maccallum Cancer CentreRecruiting
  • The Alfred HospitalRecruiting
  • Linear Clinical ResearchRecruiting
  • Perth Blood InstituteRecruiting
  • Tom Baker Cancer CenterRecruiting
  • Arensia Exploratory Medicine LlcRecruiting
  • Niguarda Cancer Center Division of HematologyRecruiting
  • Centroricerche Cliniche Di Verona SrlRecruiting
  • The Institute of Oncology, Arensia Exploratory MedicineRecruiting
  • Hospital Universitario Vall DhebronRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Karolinska Universitetssjukhuset SolnaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Part 1a (Monotherapy Dose Escalation)

Part 1b (Monotherapy Safety Expansion)

Part 1c (Additional Monotherapy Safety Expansion)

Part 2 (Monotherapy Dose Expansion)

Arm Description

Dose escalation in selected R/R B-Cell malignancies to inform safety, tolerability and MTD.

Additional participants with selected R/R B-Cell malignancies will be enrolled at selected doses to help inform the selection of the recommended phase two dose (RP2D).

After RP2D is determined, additional safety data will be collected to confirm RP2D for participants with selected B-cell malignancies not being evaluated in Part 2

The totality of the data from Part 1a and Part 1b will be used to further evaluate the safety and efficacy of BGB-16673 at the recommended dose(s) for Part 2 expansion in specific histologies.

Outcomes

Primary Outcome Measures

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and Adverse Events (AEs) graded according NCI-CTCAE V5.
TEAE is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of the first dose of the study drug and up to 30 days after the last dose of study treatment or the initiation of a new anticancer therapy, whichever is earlier
Recommended Phase 2 Dose (RP2D) of BGB-16673
RP2D is the recommended dose for further evaluation in Part 2, determined based on the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data in Part 1.
Maximum Tolerated Dose (MTD) of BGB-16673
determined by the sponsor based on the Safety Monitoring Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Part 2: Overall response rate (ORR) in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Participants
according to the Independent Review Committee (IRC) assessment based on best overall response of PR or better as determined by Lugano criteria
Part 2: ORR in relapsed/refractory chronic/small lymphocytic lymphoma (R/R CLL/SLL) Participants
as assessed by investigators based on overall response of PR-L or better as determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL )criteria

Secondary Outcome Measures

Single Dose Maximum observed plasma concentration (Cmax) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose Minimum observed plasma concentration (Cmin) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose Time to reach Cmax (tmax) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose Time to reach half of Cmax (T1/2) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose Area under the plasma concentration-time curve (AUC) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose apparent volume of distribution (Vz/F) of BGB-16673
Collected for both Part 1 and Part 2
Single Dose accumulation ratios of BGB-16673
Collected for both Part 1 and Part 2
Steady State Maximum observed plasma concentration (Cmax) of BGB-16673
Collected for both Part 1 and Part 2
Steady State minimum observed plasma concentration (Cmin) of BGB-16673
Collected for both Part 1 and Part 2
Steady State Time to reach Cmax (tmax) of BGB-16673
Collected for both Part 1 and Part 2
Steady State Time to reach half of Cmax (T1/2) of BGB-16673
Collected for both Part 1 and Part 2
Steady State Area under the plasma concentration-time curve (AUC) of BGB-16673
Collected for both Part 1 and Part 2
Steady State apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Collected for both Part 1 and Part 2
Steady State apparent volume of distribution (Vz/F) of BGB-16673
Collected for both Part 1 and Part 2
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy
Collected for both Part 1 and Part 2
Part 1: Overall response rate (ORR)
defined as the proportion of participants whose best overall response is better than stable disease.
Part 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR)
MRR is defined as the proportion of participants whose best overall response (BOR) is partial response (PR) or better (PR, very good partial response (VGPR), or complete response (CR)).
Part 2: Number of R/R MCL Participants with overall response rate (ORR)
defined as the proportion of participants whose best overall response is better than stable
Part 2: Number of R/R CLL/SLL Participants with overall response rate (ORR)
defined as the proportion of participants whose best overall response is better than stable
Part 2: Duration of Response (DOR) for R/R MCL Participants
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first [as assessed by the investigator and the IRC.
Part 2: Duration of Response (DOR) for R/R CLL/SLL Participants
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first [as assessed by the investigator and the IRC.
Part 2: Time to Response (TTR) for R/R MCL Participants
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator
Part 2: Time to Response (TTR) for R/R CLL/SLL Participants
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator
Part 2: Progression- Free Survival (PFS) for R/R MCL Participants
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC and the investigator
Part 2: Progression- Free Survival (PFS) for R/R CLL/SLL Participants
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC and the investigator
Part 2: Overall Survival (OS) for R/R MCL Participants
OS is defined as the time from first study drug administration to the date of death due to any cause
Part 2: Overall Survival (OS) for R/R CLL/SLL Participants
OS is defined as the time from first study drug administration to the date of death due to any cause
Part 2: Participant-reported outcomes (PRO) in R/R MCL participants via National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
The NFlymSI-18 is a participant-reported outcome questionnaire that is developed to measure disease-specific symptoms and/or treatment-related concerns in participants with advanced lymphoma

Full Information

First Posted
August 9, 2021
Last Updated
October 8, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05006716
Brief Title
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study consists of two main parts to explore BGB-16673 recommended dosing, a Part 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a part 2 (dose expansion cohorts)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
291 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1a (Monotherapy Dose Escalation)
Arm Type
Experimental
Arm Description
Dose escalation in selected R/R B-Cell malignancies to inform safety, tolerability and MTD.
Arm Title
Part 1b (Monotherapy Safety Expansion)
Arm Type
Experimental
Arm Description
Additional participants with selected R/R B-Cell malignancies will be enrolled at selected doses to help inform the selection of the recommended phase two dose (RP2D).
Arm Title
Part 1c (Additional Monotherapy Safety Expansion)
Arm Type
Experimental
Arm Description
After RP2D is determined, additional safety data will be collected to confirm RP2D for participants with selected B-cell malignancies not being evaluated in Part 2
Arm Title
Part 2 (Monotherapy Dose Expansion)
Arm Type
Experimental
Arm Description
The totality of the data from Part 1a and Part 1b will be used to further evaluate the safety and efficacy of BGB-16673 at the recommended dose(s) for Part 2 expansion in specific histologies.
Intervention Type
Drug
Intervention Name(s)
BGB-16673
Intervention Description
Orally administered
Primary Outcome Measure Information:
Title
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) with adverse events leading to discontinuation, and Adverse Events (AEs) graded according NCI-CTCAE V5.
Description
TEAE is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of the first dose of the study drug and up to 30 days after the last dose of study treatment or the initiation of a new anticancer therapy, whichever is earlier
Time Frame
approximately 3 years
Title
Recommended Phase 2 Dose (RP2D) of BGB-16673
Description
RP2D is the recommended dose for further evaluation in Part 2, determined based on the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data in Part 1.
Time Frame
approximately 3 years
Title
Maximum Tolerated Dose (MTD) of BGB-16673
Description
determined by the sponsor based on the Safety Monitoring Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Time Frame
approximately 3 years
Title
Part 2: Overall response rate (ORR) in Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Participants
Description
according to the Independent Review Committee (IRC) assessment based on best overall response of PR or better as determined by Lugano criteria
Time Frame
approximately 3 years
Title
Part 2: ORR in relapsed/refractory chronic/small lymphocytic lymphoma (R/R CLL/SLL) Participants
Description
as assessed by investigators based on overall response of PR-L or better as determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL )criteria
Time Frame
approximately 3 years
Secondary Outcome Measure Information:
Title
Single Dose Maximum observed plasma concentration (Cmax) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose Minimum observed plasma concentration (Cmin) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose Time to reach Cmax (tmax) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose Time to reach half of Cmax (T1/2) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose Area under the plasma concentration-time curve (AUC) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose apparent volume of distribution (Vz/F) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Single Dose accumulation ratios of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State Maximum observed plasma concentration (Cmax) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State minimum observed plasma concentration (Cmin) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State Time to reach Cmax (tmax) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State Time to reach half of Cmax (T1/2) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State Area under the plasma concentration-time curve (AUC) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Steady State apparent volume of distribution (Vz/F) of BGB-16673
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
Title
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy
Description
Collected for both Part 1 and Part 2
Time Frame
Day 1 pre-dose and 8 hours post-dose (approximately 2 years)
Title
Part 1: Overall response rate (ORR)
Description
defined as the proportion of participants whose best overall response is better than stable disease.
Time Frame
approximately 3 years
Title
Part 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR)
Description
MRR is defined as the proportion of participants whose best overall response (BOR) is partial response (PR) or better (PR, very good partial response (VGPR), or complete response (CR)).
Time Frame
approximately 3 years
Title
Part 2: Number of R/R MCL Participants with overall response rate (ORR)
Description
defined as the proportion of participants whose best overall response is better than stable
Time Frame
approximately 3 years
Title
Part 2: Number of R/R CLL/SLL Participants with overall response rate (ORR)
Description
defined as the proportion of participants whose best overall response is better than stable
Time Frame
approximately 3 years
Title
Part 2: Duration of Response (DOR) for R/R MCL Participants
Description
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first [as assessed by the investigator and the IRC.
Time Frame
approximately 3 years
Title
Part 2: Duration of Response (DOR) for R/R CLL/SLL Participants
Description
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first [as assessed by the investigator and the IRC.
Time Frame
approximately 3 years
Title
Part 2: Time to Response (TTR) for R/R MCL Participants
Description
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator
Time Frame
approximately 3 years
Title
Part 2: Time to Response (TTR) for R/R CLL/SLL Participants
Description
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator
Time Frame
approximately 3 years
Title
Part 2: Progression- Free Survival (PFS) for R/R MCL Participants
Description
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC and the investigator
Time Frame
approximately 3 years
Title
Part 2: Progression- Free Survival (PFS) for R/R CLL/SLL Participants
Description
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC and the investigator
Time Frame
approximately 3 years
Title
Part 2: Overall Survival (OS) for R/R MCL Participants
Description
OS is defined as the time from first study drug administration to the date of death due to any cause
Time Frame
approximately 3 years
Title
Part 2: Overall Survival (OS) for R/R CLL/SLL Participants
Description
OS is defined as the time from first study drug administration to the date of death due to any cause
Time Frame
approximately 3 years
Title
Part 2: Participant-reported outcomes (PRO) in R/R MCL participants via National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
Description
The NFlymSI-18 is a participant-reported outcome questionnaire that is developed to measure disease-specific symptoms and/or treatment-related concerns in participants with advanced lymphoma
Time Frame
approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) (Part 1a 1b, and 1c only), Follicular Lymphoma (FL) (Part 1a and 1c only), R/R MCL (parts 1a, 1b, and 2 only), R/R CLL/SLL (Parts 1a, 1b, and 2), WM (Part 1a and 1c only), DLBCL (Part 1a and 1c only), or >2 treatments per the Richter's transformation to DLBCL (Part 1a and 1c only). Participants who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance). For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance. Measurable disease by radiographic assessment or serum IgM level (WM only) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2) must have been treated with a BTKi in a prior line of therapy. Exclusion Criteria: Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer Requires ongoing systemic treatment for any other malignancy Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected Richter's transformation of an indolent lymphoma to an aggressive histology (only participants with Richter Transformation to DLBCL are eligible for Part 1a and 1c). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1.877.828.5568
Email
clinicaltrials@beigene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director, MD
Facility Information:
Facility Name
University of Alabama At Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego (Ucsd) Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Santa Monica Cancer Care
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Hospital Cancer Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute Pavilion
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Cancer Specialists
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College Newyork Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center Mskcc
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincents Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter Maccallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Perth Blood Institute
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Arensia Exploratory Medicine Llc
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Niguarda Cancer Center Division of Hematology
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centroricerche Cliniche Di Verona Srl
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
The Institute of Oncology, Arensia Exploratory Medicine
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall Dhebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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