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BGB-16673

Phase 3

Chronic Lymphocytic Leukemia | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Jul 24, 2026

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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment653
FDA Designations
No designations recorded
Clinical trial landscape

BGB-16673 · 9 trials · 18 indications

Phase 3 3Phase 1 6
NCT06973187A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaChronic Lymphocytic Leukemia
RECRUITING500 Analytics
NCT06970743A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) InhibitorsChronic Lymphocytic Leukemia
ACTIVE NOT_RECRUITING153 Analytics
NCT06846671A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) InhibitorsCLL
RECRUITING250 Analytics
PHASE3RECRUITING
A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Chronic Lymphocytic LeukemiaUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
Chronic Lymphocytic LeukemiaUnlock trial analytics
PHASE3RECRUITING
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
CLLUnlock trial analytics
Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS) per Independent Review Committee (IRC)
Up to approximately 3 years

PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).

Progression-Free Survival (PFS) by IRC
Approximately 23 Months

PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with R/R CLL and the Lugano Classification for patients with R/R SLL.

Progression-Free Survival (PFS) by Independent Review Committee (IRC)
Approximately 36 Months

PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).

Number of participants with adverse events (AEs)
Up to approximately 4 months

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including findings from laboratory tests and electrocardiogram results.

Maximum observed plasma concentration (Cmax) of BGB-16673
Up to approximately 10 weeks
Minimum observed plasma concentration (Cmin) of BGB-16673
Up to approximately 10 weeks
Time to reach maximum observed plasma concentration (Tmax) of BGB-16673
Up to approximately 10 weeks
Apparent terminal elimination half life (t1/2) of BGB-16673
Up to approximately 10 weeks
Area under the curve (AUC) of BGB-16673
Up to approximately 10 weeks
Apparent oral clearance (CL/F) of BGB-16673
Up to approximately 10 weeks
Apparent volume of distribution (Vz/F) of BGB-16673
Up to approximately 10 weeks
Accumulation Ratio of AUC for BGB-16673
Up to approximately 10 weeks
Accumulation Ratio of Cmax for BGB-16673
Up to approximately 10 weeks
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673
Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) for Total Radioactivity in Plasma and Whole Blood
Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673
Approximately 35 Days
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) for Total Radioactivity in Plasma and Whole Blood
Approximately 35 Days
Maximum Observed Plasma Concentration (Cmax) for Total Radioactivity in Plasma and Whole Blood
Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) of BGB-16673
Approximately 35 Days
Time of the Maximum Observed Plasma Concentration (Tmax) for Total Radioactivity in Plasma and Whole Blood
Approximately 35 Days
Apparent Terminal Elimination Half-life (t1/2) of BGB-16673
Approximately 35 Days
Apparent Terminal Elimination Half-life (t1/2) for Total Radioactivity in Plasma and Whole Blood
Approximately 35 Days
Urinary recovery of BGB-16673 (fet1-t2)
Approximately 35 Days
Quantitative metabolic profiles of BGB-16673 in plasma and excreta
Approximately 35 Days
Identification of BGB-16673 major metabolites in plasma and excreta
Approximately 35 Days
Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 3 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 3 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years]
Substudy 4 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Substudy 4 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
From first dose of the study drug(s) to 30 days after the last dose or before initiation of a new anticancer therapy, whichever occurs first (up to approximately 3 years)

Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE 5.0), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria.

Phase 1: Recommended Phase 2 dose (RP2D) of BGB-16673
From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)

As determined by the sponsor based on the Safety Monitoring Committee's recommendation considering totality of the available clinical safety, clinical efficacy, pharmacokinetics, and pharmacodynamics data.

Phase 1a: Maximum tolerated dose (MTD) of BGB-16673
From the date of first dose of study drugs until RP2D is determined (up to approximately 37 weeks)

The highest dose evaluated as recommended by the Bayesian Optimal Interval Design with Informative Prior (iBOIN) design or the maximum assessed dose (MAD).

Phase 2: Overall Response Rate (ORR) in participants with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)
Up to approximately 3 years

ORR is defined as the percentage of participants with partial response or better according to the Independent Review Committee (IRC) assessment and as determined by Lugano criteria.

Phase 2: ORR in participants with R/R Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Up to approximately 3 years

ORR is defined as the percentage of participants with partial response or better as assessed by the IRC and determined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL and by Lugano criteria for SLL

Phase 1: Number of Participants with Adverse Events (AEs)
From the first dose of BGB-16673 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)

Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-16673
Approximately 28 days

MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached.

Phase 1: Recommended dose(s) for Expansion (RDFE) of BGB-16673
Approximately 3 years

RDFE of BGB-16673 alone will be determined based upon the MTD or MAD.

Phase 2: Overall response rate (ORR)
approximately 3 years

Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM.

Secondary Endpoints
Overall Survival (OS)
Up to approximately 3 years
PFS per Investigator (INV)
Up to approximately 3 years
Overall Response Rate (ORR) per IRC and INV
Up to approximately 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: BGB-16673EXPERIMENTALParticipants will receive BGB-16673 orally.
Arm B: PirtobrutinibACTIVE_COMPARATORParticipants will receive pirtobrutinib orally.
Arm A: BGB-16673 MonotherapyEXPERIMENTALParticipants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Arm B: Investigator's ChoiceACTIVE_COMPARATORParticipants will receive investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab or chlorambucil plus obinutuzumab for up to six 28-day cycles. Participants with unequivocal disease progression confirmed by Independent Review Committee (IRC) may cross over to receive treatment with BGB-16673 at the Investigator's discretion
BGB-16673EXPERIMENTALParticipants will receive BGB-16673 orally
PlaceboPLACEBO_COMPARATORParticipants will receive placebo orally for 28 days and then crossover to receive BGB-16673.
Part A: BGB-16673 + Phenytoin (CYP3A Inducer)EXPERIMENTALParticipants will receive multiple doses of Phenytoin to determine its effect on BGB-16673
Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor)EXPERIMENTALParticipants will receive multiple doses of Itraconazole to determine its effect on BGB-16673
Single Arm: [14C]-BGB-16673EXPERIMENTALParticipants will receive a single dose of \[14C\]-BGB-16673
Substudy 1 Part 1a: Dose EscalationEXPERIMENTALSequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Substudy 1 Part 1b: Safety ExpansionEXPERIMENTALCohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Substudy 2 Part 1a: Dose EscalationEXPERIMENTALSequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Substudy 2 Part 1b: Safety ExpansionEXPERIMENTALCohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Substudy 3 Part 1a: Dose EscalationEXPERIMENTALSequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Substudy 3 Part 1b: Safety ExpansionEXPERIMENTALCohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Substudy 4 Part 1a: Dose EscalationEXPERIMENTALSequential cohorts of increasing dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
Substudy 4 Part 1b: Safety ExpansionEXPERIMENTALCohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.
Phase 1a Monotherapy Dose EscalationEXPERIMENTALBGB-16673 will be orally administered.
Phase 1b Monotherapy Safety ExpansionEXPERIMENTALBGB-16673 will be orally administered.
Phase 2 Monotherapy Dose ExpansionEXPERIMENTALBGB-16673 will be administered at the recommended Phase 2 dose (RP2D) that was identified in Part 1.
Part 1a (Monotherapy Dose Escalation)EXPERIMENTALDose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), R/R follicular lymphoma (FL) Grades 1, 2, and 3a, R/R mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), R/R diffuse large B-cell lymphoma (DLBCL), R/R Richter's transformation (RT), and R/R Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of BGB-16673.
Part 1b (Monotherapy Safety Expansion)EXPERIMENTALParticipants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for BGB-16673.
Part 1c (Additional Monotherapy Safety Expansion)EXPERIMENTALAdditional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of BGB-16673 for those with non-CLL/SLL/MCL histologies.
Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL)EXPERIMENTALParticipants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for BGB-16673.
Part 1e (Japan-only Cohort)EXPERIMENTALJapanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of BGB-16673.
Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)EXPERIMENTALParticipants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels.
Phase 2 (Monotherapy Expansion)EXPERIMENTALCohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of BGB-16673.
Interventions
NameTypeDescription
BGB-16673DRUGBGB-16673 will be administered orally
PirtobrutinibDRUGPirtobrutinib will be administered orally
BendamustineDRUGAdministered intravenously
RituximabDRUGAdministered intravenously
MethylprednisoloneDRUGAdministered intravenously
ChlorambucilDRUGAdministered orally
ObinutuzumabDRUGAdministered intravenously
IdelalisibDRUGAdministered orally
VenetoclaxDRUGAdministered orally
PlaceboDRUGAdministered orally
ItraconazoleDRUGAdministered orally
PhenytoinDRUGAdministered orally
[14C]-BGB-16673DRUGAdministered orally as suspension in lipid vehicle
SonrotoclaxDRUGAdministered orally
ZanubrutinibDRUGAdministered orally
MosunetuzumabDRUGAdministered subcutaneously
GlofitamabDRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites197

Inclusion Criteria: * Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria * Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy in...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilChinaFranceGermanyIsraelItalyJapanMexicoNetherlandsNew ZealandPolandPuerto RicoRomaniaSingaporeSouth KoreaSpainSwedenSwitzerlandUnited KingdomTaiwanCanadaCzechiaTurkey (Türkiye)GeorgiaMoldova
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Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT05006716lastUpdatePostDate: changed
LOWJul 24, 2026NCT06634589lastUpdatePostDate: changed
LOWJul 24, 2026NCT06973187lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT06970743enrollmentType: changed
LOWJul 24, 2026NCT05006716lastUpdatePostDate: changed
LOWJul 24, 2026NCT06973187lastUpdatePostDate: changed
LOWJul 24, 2026NCT06634589lastUpdatePostDate: changed
MEDIUMJul 24, 2026NCT06970743enrollmentType: changed
LOWJul 22, 2026NCT06846671lastUpdatePostDate: changed
LOWJul 22, 2026NCT06846671lastUpdatePostDate: changed
LOWJul 10, 2026NCT06973187lastUpdatePostDate: changed
LOWJul 10, 2026NCT06634589lastUpdatePostDate: changed
LOWJul 10, 2026NCT06973187lastUpdatePostDate: changed
LOWJul 10, 2026NCT06634589lastUpdatePostDate: changed
LOWJul 9, 2026NCT06846671lastUpdatePostDate: changed
LOWJul 9, 2026NCT06846671lastUpdatePostDate: changed
MEDIUMJun 29, 2026NCT06970743Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 29, 2026NCT06970743Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 22, 2026NCT06970743lastUpdatePostDate: changed
LOWJun 22, 2026NCT06846671lastUpdatePostDate: changed