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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05006716
Registration number
NCT05006716
Ethics application status
Date submitted
9/08/2021
Date registered
16/08/2021
Date last updated
6/06/2024
Titles & IDs
Public title
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
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Scientific 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
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Secondary ID [1]
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0
2022-502157-33-00
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Secondary ID [2]
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BGB-16673-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
B-cell Malignancy
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0
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Marginal Zone Lymphoma
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0
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Follicular Lymphoma
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0
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Non-Hodgkin Lymphoma
0
0
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Waldenström Macroglobulinemia
0
0
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Chronic Lymphocytic Leukemia
0
0
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Small Lymphocytic Lymphoma
0
0
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Mantle Cell Lymphoma
0
0
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Diffuse Large B Cell Lymphoma
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-16673
Experimental: Part 1a (Monotherapy Dose Escalation) - Dose escalation in selected R/R B-Cell malignancies to inform safety, tolerability and MTD.
Experimental: Part 1b (Monotherapy Safety Expansion) - 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).
Experimental: Part 1c (Additional Monotherapy Safety Expansion) - 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
Experimental: Part 2 (Monotherapy Expansion) - The totality of the data from Part 1a, Part 1b, and Part 1c will be used to further evaluate the safety and efficacy of BGB-16673 at the recommended dose(s) for Phase 2 expansion in specific histologies.
Treatment: Drugs: BGB-16673
Orally administered
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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
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Timepoint [1]
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approximately 3 years
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Primary outcome [2]
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Recommended Phase 2 Dose (RP2D) of BGB-16673
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Assessment method [2]
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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.
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Timepoint [2]
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0
approximately 3 years
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Primary outcome [3]
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Maximum Tolerated Dose (MTD) of BGB-16673
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Assessment method [3]
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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
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Timepoint [3]
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approximately 3 years
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Primary outcome [4]
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Phase 2: Overall response rate (ORR)
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Assessment method [4]
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Cohort specific ORRs based on best overall response of partial response (PR) or better as assessed by Independent Review Committee (IRC) for prticipants in cohorts 1 and 2; by investigator for other cohorts.
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Timepoint [4]
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approximately 3 years
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Secondary outcome [1]
0
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Single Dose Maximum observed plasma concentration (Cmax) of BGB-16673
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Assessment method [1]
0
0
Collected for both Part 1 and Part 2
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Timepoint [1]
0
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Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [2]
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Single Dose Minimum observed plasma concentration (Cmin) of BGB-16673
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Assessment method [2]
0
0
Collected for both Part 1 and Part 2
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Timepoint [2]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [3]
0
0
Single Dose Time to reach Cmax (tmax) of BGB-16673
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Assessment method [3]
0
0
Collected for both Part 1 and Part 2
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Timepoint [3]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [4]
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0
Single Dose Time to reach half of Cmax (T1/2) of BGB-16673
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Assessment method [4]
0
0
Collected for both Part 1 and Part 2
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Timepoint [4]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [5]
0
0
Single Dose Area under the plasma concentration-time curve (AUC) of BGB-16673
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Assessment method [5]
0
0
Collected for both Part 1 and Part 2
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Timepoint [5]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [6]
0
0
Single Dose apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
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Assessment method [6]
0
0
Collected for both Part 1 and Part 2
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Timepoint [6]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [7]
0
0
Single Dose apparent volume of distribution (Vz/F) of BGB-16673
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Assessment method [7]
0
0
Collected for both Part 1 and Part 2
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Timepoint [7]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [8]
0
0
Single Dose accumulation ratios of BGB-16673
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Assessment method [8]
0
0
Collected for both Part 1 and Part 2
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Timepoint [8]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [9]
0
0
Steady State Maximum observed plasma concentration (Cmax) of BGB-16673
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Assessment method [9]
0
0
Collected for both Part 1 and Part 2
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Timepoint [9]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [10]
0
0
Steady State minimum observed plasma concentration (Cmin) of BGB-16673
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Assessment method [10]
0
0
Collected for both Part 1 and Part 2
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Timepoint [10]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [11]
0
0
Steady State Time to reach Cmax (tmax) of BGB-16673
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Assessment method [11]
0
0
Collected for both Part 1 and Part 2
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Timepoint [11]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [12]
0
0
Steady State Time to reach half of Cmax (T1/2) of BGB-16673
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Assessment method [12]
0
0
Collected for both Part 1 and Part 2
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Timepoint [12]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [13]
0
0
Steady State Area under the plasma concentration-time curve (AUC) of BGB-16673
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Assessment method [13]
0
0
Collected for both Part 1 and Part 2
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Timepoint [13]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [14]
0
0
Steady State apparent total clearance of drug from plasma after oral administration (CL/F) of BGB-16673
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Assessment method [14]
0
0
Collected for both Part 1 and Part 2
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Timepoint [14]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [15]
0
0
Steady State apparent volume of distribution (Vz/F) of BGB-16673
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Assessment method [15]
0
0
Collected for both Part 1 and Part 2
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Timepoint [15]
0
0
Day 1 pre-dose and 2, 4, 6,8,24, 48 and 72 hours post-dose (approximately 2 years)
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Secondary outcome [16]
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0
Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after BGB-16673 monotherapy
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Assessment method [16]
0
0
Collected for both Part 1 and Part 2
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Timepoint [16]
0
0
Day 1 pre-dose and 8 hours post-dose (approximately 2 years)
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Secondary outcome [17]
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0
Phase 1: Overall response rate (ORR)
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Assessment method [17]
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0
defined as the proportion of participants whose best overall response is better than stable disease.
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Timepoint [17]
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0
approximately 3 years
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Secondary outcome [18]
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0
Phase 1: Number of Waldenström Macroglobulinemia (WM) Participants with major response rate (MRR)
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Assessment method [18]
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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)).
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Timepoint [18]
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0
approximately 3 years
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Secondary outcome [19]
0
0
Phase 2: Duration of Response (DOR)
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Assessment method [19]
0
0
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.
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Timepoint [19]
0
0
approximately 3 years
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Secondary outcome [20]
0
0
Phase 2: Time to Response (TTR)
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Assessment method [20]
0
0
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
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Timepoint [20]
0
0
approximately 3 years
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Secondary outcome [21]
0
0
Phase 2: Progression- Free Survival (PFS)
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Assessment method [21]
0
0
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
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Timepoint [21]
0
0
approximately 3 years
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Secondary outcome [22]
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Phase 2: Overall Survival (OS)
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Assessment method [22]
0
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OS is defined as the time from first study drug administration to the date of death due to any cause
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Timepoint [22]
0
0
approximately 3 years
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Secondary outcome [23]
0
0
Phase 2 (Cohort 1): Best Overall Response (BOR) of partial response with lymphocytosis or better
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Assessment method [23]
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0
Best overall response is defined as the best response recorded from the first dose of the study drug until the data cutoff date or initiation of a new anticancer treatment, whichever occurs first. As determined by IRC and investigators.
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Timepoint [23]
0
0
approximately 3 years
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Secondary outcome [24]
0
0
Phase 2 (Cohort 3): BOR of minor response or better
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Assessment method [24]
0
0
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Timepoint [24]
0
0
approximately 3 years
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Secondary outcome [25]
0
0
Phase 2 (Cohort 1): Participant-reported outcomes (PRO) via Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionarre
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Assessment method [25]
0
0
FACT-Leu is a PRO questionnaire that is developed to measure disease-specific symptoms and/or treatment-related concerns in participants with leukemia (Cela et al. 2012). It has been linguistically validated in over 50 languages, and frequently to measure HRQoL in chronic lymphocytic leukemia (CLL) participants.
The questionnaire is comprised of 44 questions and 5 subscales including Physical Well-being (7 items), Social / Family Well-being (7 items), Emotional Well-being (6 items), Functional Wellbeing (7 items), and 17 single items under Additional Concerns).
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Timepoint [25]
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0
approximately 3 years
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Secondary outcome [26]
0
0
Phase 2 (Cohort 2): Participant-reported outcomes (PRO) via National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
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Assessment method [26]
0
0
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
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Timepoint [26]
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0
approximately 3 years
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Eligibility
Key inclusion criteria
Inclusion Criteria :
1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise
noted) of one of the following: Marginal Zone Lymphoma (MZL) , Follicular Lymphoma
(FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia and small
lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuse large
B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation to DLBCL.
2. Participants who have previously received a covalently-binding Bruton´s tyrosine
kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with
the BTK inhibitor for = 8 weeks (unless reason for discontinuation is intolerance).
3. 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.
4. Measurable disease by radiographic assessment or serum IgM level (WM only)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
6. 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 MCL enrolling in the expansion cohorts (Phase
2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL
participants, in addition to being treated with a BTKi in a prior line of therapy,
must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase
2).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior malignancy (other than the disease under study) within the past 2 years, except
in situ malignancies that have been curatively resected, localized breast cancer
treated with curative intent with no evidence of breast active disease for more than 3
years and receiving adjuvant hormonal therapy, localized Gleason score = 6 prostate
cancer undergoing observation or treatment with androgen depravation, or any other
cancer treated with curative intent, not on adjuvant treatment, and in the opinion of
the investigator is unlikely to recur.
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 participants 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, germinal
center B-cell (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
transformation of an indolent lymphoma to an aggressive histology (except for
participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or
Phase 2 and participants with history of follicular lymphoma transforming to non-GCB
DLBCL who are eligible for Part 1a, 1c, or Phase 2).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/03/2028
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Actual
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Sample size
Target
466
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Brisbane
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Recruitment hospital [3]
0
0
St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [4]
0
0
Peninsula Private Hospital - Frankston
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Recruitment hospital [5]
0
0
Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [6]
0
0
The Alfred Hospital - Melbourne
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Recruitment hospital [7]
0
0
Linear Clinical Research - Nedlands
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Recruitment hospital [8]
0
0
Perth Blood Institute - West Perth
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Recruitment postcode(s) [1]
0
0
2139 - Concord
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Recruitment postcode(s) [2]
0
0
4102 - Brisbane
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Recruitment postcode(s) [3]
0
0
3065 - Fitzroy
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Recruitment postcode(s) [4]
0
0
3199 - Frankston
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Recruitment postcode(s) [5]
0
0
3000 - Melbourne
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Recruitment postcode(s) [6]
0
0
3004 - Melbourne
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Recruitment postcode(s) [7]
0
0
6009 - Nedlands
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Recruitment postcode(s) [8]
0
0
6005 - West Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Iowa
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Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
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Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
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Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Michigan
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Minnesota
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Nebraska
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Nevada
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Jersey
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Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
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Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Virginia
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Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Caxias do Sul
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Curitiba
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Sao Paulo
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Country [23]
0
0
Canada
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State/province [23]
0
0
Alberta
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Country [24]
0
0
Canada
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State/province [24]
0
0
Quebec
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Country [25]
0
0
France
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State/province [25]
0
0
Bordeaux
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Country [26]
0
0
France
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State/province [26]
0
0
Clermont Ferrand
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Country [27]
0
0
France
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State/province [27]
0
0
Creteil
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Country [28]
0
0
France
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State/province [28]
0
0
Lille
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Country [29]
0
0
France
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State/province [29]
0
0
Marseille
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Country [30]
0
0
France
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State/province [30]
0
0
Montpellier Cedex
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Country [31]
0
0
France
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State/province [31]
0
0
Paris
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Country [32]
0
0
France
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State/province [32]
0
0
Rouen Cedex
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Country [33]
0
0
Georgia
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State/province [33]
0
0
Tbilisi
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Country [34]
0
0
Germany
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State/province [34]
0
0
Luebeck
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Country [35]
0
0
Germany
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State/province [35]
0
0
Ulm
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Country [36]
0
0
Italy
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State/province [36]
0
0
Bologna
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Country [37]
0
0
Italy
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State/province [37]
0
0
Milano
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Country [38]
0
0
Italy
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State/province [38]
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0
Roma
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Country [39]
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Italy
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State/province [39]
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Verona
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Country [40]
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Korea, Republic of
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State/province [40]
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Busan Gwang'yeogsi
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Korea, Republic of
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State/province [41]
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Seoul Teugbyeolsi
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Country [42]
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Moldova, Republic of
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State/province [42]
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Chisinau
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Valencia
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Country [47]
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Sweden
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Goteborg
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Country [48]
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Headington
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United Kingdom
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Leeds
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United Kingdom
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NewCastle Upon Tyne
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Ethics approval
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Summary
Brief summary
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1
monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety
expansion of selected doses, and a Phase 2 (expansion cohorts)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05006716
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
Name
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BeiGene
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Address
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Phone
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1.877.828.5568
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05006716
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